A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
Phase: NA
Conditions: Intervention
Sponsor: Scion NeuroStim

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FINAL           August 9, 2016 
SCION NEUROSTIM, LLC:   
 
Title: A Non-Invasive Neuromodulation Device for Prevention 
of Episodic Migraine Headache 
 
Background  
This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial 
for adjunctive prophylactic treatment of episodic migraine headache (with or without 
aura) using a caloric vestibular stimulation (CVS) device developed by Scion NeuroStim, 
LLC (SNS).  The investigational use of the CVS device for episodic migraine headache 
has been reviewed by the FDA and is classified as NSR (non-significant risk). 
 
Efficacy of neuromodulation therapy for migraines is reasonably well-established.  
Traditionally, however, neuromodulation, especially when accomplished through an 
expensive, surgically implanted device, has been available only as a treatment of last 
resort, to be used (and covered by health insurance) if, but only after, patients have failed 
all other interventions, principally pharmaceuticals.  Typically, patients receive 
neuromodulation for migraines only after they are refractory or close to being refractory.  
SNS envisions changing that paradigm, providing effective early interventions and 
thereby improving outcomes for migraine patients.  The CVS device is non-invasive and 
utilizes the same underlying mode of neural modulation (activation of the vestibular 
nuclei in the brainstem) that for a century has been well-understood by the medical 
profession and has been used safely via caloric irrigators for diagnostic purposes, for 
example in ENT practices to assess balance and in the ED to assess brain function.   The 
device is easy to operate; it can be used safely at home by a patient under the supervision 
of a prescribing physician.   Through availability and use of the CVS device, prophylactic 
neuromodulation therapy for migraines can become an inexpensive and early, rather than 
an expensive and belated, therapeutic option.  
 
A pivotal RCT study of episodic migraine headache using the device has been completed 
(NCT01899040).  The primary endpoint was met.  Active arm subjects showed 
immediate and steady declines in migraine days over the treatment period and exhibited 
significantly fewer migraines during the third treatment month (-3.6 ± 0.7 days, -46.1% ± 
7.3%), than placebo arm subjects (-0.9 ± 0.7 days, 13.5% ± -14.1%, p = 0.014).   The 
study described herein is designed to further the evaluation of CVS neuromodulation, 
addressing the following aims: 
1. To gather additional safety and efficacy data and reaffirm that using the CVS 
device leads to a significant reduction in migraine headache days relative to a 
placebo. 
2. To extend the treatment period from 3-months to 6-months, with all subjects 
(including placebo) receiving active treatment in the second 3-month period. 
3. To test the efficacy of once-per-day active treatments versus twice-per-day active 

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treatments.   
4. To evaluate the durability of gains realized after the end of the treatment period 
through an additional 3-month long headache diary period. 
 
All participants will be subjects whose response to prior therapies has been partially 
successful, but limited.  As defined in detail below, under International Headache Society 
(IHS) guidelines all of these subjects will be classified as “episodic” or acute.  None will 
be classified as “chronic.”  In assessing the effectiveness of the CVS device, the study 
will consider both (1) a subject’s number of headaches as well as (2) the severity of each 
and of all of those headaches. The primary endpoint is based on outcomes data collected 
during the treatment period vs. the pre-treatment baseline period, focusing on the 
comparative number of migraine headache days.  
 
 
Description of the Treatment Paradigm and Study 
 
1)  Intended Use/Indication for Use 
 
• Intended Use: The CVS device is intended to stimulate the vestibular system via 
external ear canals using controlled thermal waveforms.  
• Indication for Use: The CVS device is indicated for use in the prevention of 
episodic migraine headache. 
 
2)  Subject Selection Criteria Pre-Treatment Data   
In working with and through their respective designated assistant(s)/coordinator(s), the 
principal investigators will identify and screen potential participants, all of whom will 
have previously been diagnosed as episodic migraine headache subjects. The 
investigators will review the subjects' medical records to select those individuals who 
they identify as meeting the inclusion criteria for participating in the study.  
• Inclusion Criteria: Each participant must have a pre-treatment history that, when 
initially screened by a principal investigator or designee, documents that she/he 
meets all elements of the following:   
o The subject must have been diagnosed with episodic migraine headache at 
least six months prior to entering into the Study, consistent with the 
International Headache Classification of Headache Disorders (ICHD-II 
and ICHD-III beta) guidelines. 
o The subject must have a history of at least three consecutive months of 
stable migraine headaches prior to entering the study.  The subjects will 
not have had changes in medication usage (prescription medications for 
migraine headache) for the three months leading up to the study, nor will 
they introduce new medications during the study period. (The primary 
focus is on prescription medications for migraine headache.  However, 
medications that are prescribed for co-morbid conditions which also have 

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demonstrated efficacy for migraine prevention should not be altered in this 
time period.)  
o Subjects will satisfy these criteria: On a monthly basis, at least four, and 
not more than a total of fourteen (4-14), headache days of which between 
four and fourteen (4-14) are migraine headache days, as judged by the 
subject. 
o The subject must not have failed on more than two classes of properly 
administered 
prophylactic 
pharmaceutical 
therapies 
for 
migraine 
headache.  The subject may be on a single migraine prophylactic drug as 
long as the dosage has not been altered within three months of starting the 
study and the dosage must not be altered for the duration of the study; 
o The Investigator must have confidence in the subject's ability to reliably 
use the CVS device and promptly complete the electronic daily headache 
diary forms.  The daily headache diary will be completed from the 
beginning of the pre-treatment baseline period through the end of the 
study. The diary is described more fully below and in the definitions 
section at the end of this document. 
 
• Exclusion Criteria: Individuals who:  
o have previously participated in a clinical trial using the CVS Device 
o are pregnant  
o using more than one concurrent prophylactic pharmaceutical therapy for 
migraine headache 
o have a history of cardiovascular disease  
o work night shifts 
o have been diagnosed with vestibular migraine  
o have menstrual migraine exclusively  
o have been diagnosed with post-traumatic migraine   
o have a history of unstable mood disorder or unstable anxiety disorder.  
Specifically, a BDI-II score of 20 or greater and/or a BAI score of 16 or 
greater will disqualify a patient from randomizing into the treatment 
portion of the study. 
o use a hearing aid 
o have a cochlear implant 
o have chronic tinnitus 
o have temporomandibular joint disease 
o have been diagnosed with traumatic brain injury 
o have been diagnosed with neurological disease other than headaches 

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o have a diagnosed vestibular dysfunction and/or balance dysfunction  
o have a history of abusing alcohol or other drugs 
o are experiencing medication overuse headaches (individuals with respect 
to whom the principal investigator is concerned that analgesic abuse is 
involved based on the ICHD-II guidelines).  
o are less than 18 years old or greater than 65 years old 
o have had eye surgery within the previous three months or ear surgery 
within the previous six months   
o have active ear infections or a perforated tympanic membrane 
o have participated in another clinical trial within the last 30 days or are 
currently enrolled in another clinical trial   
o are using Botulinum toxin-based treatments for migraines or for facial 
cosmetic reasons. 
o are taking anti-emetics chronically (more than 2 times per week, 
consistently) 
o Though not excluded, subjects taking anti-histamines will be encouraged 
not to take such medications within four hours prior to a CVS treatment.  
The investigator should review other medications taken by the subject 
with properties that mimic anti-nausea or anti-dizziness drugs as these 
may reduce responsiveness of the vestibular system to caloric stimulation.  
Such medications should also be avoided within four hours prior to a CVS 
treatment. 
 
• Withdrawal Criteria 
o Subjects must be withdrawn from the clinical trial if any of the following 
events occur: 
§ Surgery during the study period. 
§ A subject does not continue to meet inclusion/exclusion criteria. 
§ A subject is significantly non-compliant with the requirements of 
the protocol (principle investigator & sponsor decision). 
§ The subject does not complete at least 25 of 28 daily diary entries 
in her/his headache diary during the baseline period.  (That is, the 
subject must be compliant with maintaining the headache diary.) 
§ A subject becomes pregnant during the trial as evidenced by a 
positive pregnancy test. 
§ The subject develops an illness (adverse event) that would interfere 
with his/her continued participation. 
§ The subject withdraws his/her consent. 
§ The principal investigator feels that it is the subject's best interest 
to be withdrawn. 
§ Scion Neurostim discontinues the study or has achieved the 
targeted enrollment.   

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If the subject is discontinued from the participation in the study for any 
reason, the principal investigator must make every effort to perform all 
evaluations for the final visit and document the reasons for 
discontinuation.  If a subject withdraws due to an adverse event, the study 
coordinator will follow up with regular phone calls to document the 
resolution of the event. 
 
Though a subject will not be withdrawn from the study if she/he exceeds 
14 headache days in any of the treatment months, such subjects will be 
grouped separately during the final study analysis.  The rationale for this 
grouping is that a large percentage of subjects in the first CVS migraine 
RCT were excluded from randomization because they exceeded 14 
headache days, thus calling into question their stable episodic status.  If a 
subject has a “good month” during baseline, but is potentially unstable, 
she/he might be recruited into the study in violation of the aim of enrolling 
stable EM subjects.  No evidence that the CVS device increased headache 
burden was seen in the first RCT.  However, we will continue to follow 
subjects who exceed 14 headache days in a month during the treatment 
period so as to gather more data on this sub-population.   
 
• Concomitant Medications 
o The use of acute abortive medications for the symptomatic treatment of 
migraine headache will be allowed during the clinical trial. Subjects may 
use their usual acute abortive medications, and medications should not be 
changed during the clinical trial.  A treated migraine headache is one for 
which a subject has taken an acute abortive medication (prescription 
medication, not OTC). 
o The subject may be on a single migraine prophylactic drug as long as the 
dosage has not been altered within three months of starting the study and 
the dosage must not be altered for the duration of the study.  The subject 
must not have failed on more than two classes of properly administered 
prophylactic pharmaceutical therapies for migraine headache. Prophylactic 
medications used to treat other medical conditions may be used, at the 
principal investigator's discretion, if the subject is taking a stable dose for 
at least three months prior to screening and continues throughout the 
study. 
 
3)  Pivotal Study Size; Randomization 
The design size contemplates enrolling up to one hundred and twenty (120) subjects who 
will successfully follow through to completion of their participation in at least the first 
treatment portion of the study (first 3-month treatment period).  The subjects will be 
randomly assigned to: twice-per-day active, once-per-day active or twice-per-day placebo 
in a 1:1:1 ratio. 
The results of the first migraine RCT did not show evidence of stratification based on 
gender or clinical site or baseline headache frequency. Envelopes containing 

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randomization assignments will be grouped in batches of six, each batch containing two 
of each of the three assignment arms.  The batches of envelopes will be randomly 
shuffled by an agent not involved with the study. A given batch will be completed before 
the next batch is opened. This procedure results in 20 possible different arrangements, for 
six subjects, of the ordering of treatment and placebo assignments. The unblinded 
coordinator will record the subject’s designation but will not share the assignment with 
the subject, principal investigator, or statistician.  Each study site will be individually 
randomized (no central randomization). 
The assessment of the primary endpoint will be completed by a blinded, central 
statistician. The subjects will be told, within the informed consent document, of the 
existence of a placebo arm.  Subjects will be told that the device stimulates the brain 
stem. Subjects will be told that they will receive at least 3-months of active treatment 
during the 6-month treatment period.  In fact, subjects in the placebo arm in the first 3-
month period will be switched to active in the second 3-month period.  Subjects will be 
asked to guess (and provide reasons) about their treatment assignment at the end of the 
first 3-month treatment period and at the end of the second 3-month treatment period.  
Subjects will also be asked, after their very first treatment in the clinic, a series of 
questions designed to assess the quality of blinding (to provide evidence that the placebo 
device is an effective sham). 
 
4)  Study Schedule; Subject Enrollment and Activities 
The study period will last 280 days (plus additional visit window days, as needed), 
beginning with a pre-treatment baseline period of one month (28 days), at the end of 
which the principal investigator will reconfirm the appropriateness of the subject’s 
participation in the study, followed by a first treatment period of three months (84 days), 
followed by a second treatment period of three months (84 days), followed by a post-
treatment diary period of three months (84 days). 
 
As noted, subjects will be advised that during the study period they may maintain 
patterns of usage of approved therapeutic medications that they normally use and that 
they should not initiate new medications, medicating patterns or other interventions. 
Accommodations for rescue medications will be made. 
 
The study will be segmented with the following aims: 
 
1. Baseline period and the first 3-month treatment period:  This portion of the 
study will be viewed as a complete RCT in-and-of itself and will be analyzed 
while the remainder of the study is still underway.  The primary endpoint 
applies to this portion of the study.  Subjects will use an electronic data capture 
system that records headache pain level, duration and associated symptoms, acute 
medication use, and whether the headache was a migraine headache.  Also, 
subjects will record any occurrence of an adverse event (AE). 
2. Months 5-7 (from the start of the baseline period): All subjects will be assigned to 
the active device. Subjects will treat with the same frequency as they did in the 
first 3-month treatment period (e.g., BID in the first period means BID in the 
second period).  Subjects will record the occurrence of a headache and whether 

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the headache was a migraine headache.  Subjects will report any adverse events to 
the unblinded site coordinator. 
3. Months 8-10 (from the start of the baseline period): Subjects will no longer be 
treating with the CVS device.  Subjects will record the occurrence of a headache 
and whether the headache was a migraine headache.  Subjects will report any 
adverse events to the unblinded site coordinator. 
 
The phases and activities of the study are listed below: 
(i) 
Screening & Baseline Period: Once the subject has been established as 
having the appropriate pre-treatment history, she/he will be asked to complete 
a review of the informed consent.  If the subject agrees to participate in the 
study, the subject will then complete a screening visit. The study coordinator 
will complete a headache history questionnaire for the subject.  If the subject is 
recommended for continuation in the study after the screening visit and 
tentatively approved by a principal investigator, she/he will start a daily 
headache diary and continue to make entries for twenty-eight consecutive 
days.  Subjects will be given Scion email accounts to be used for submitting 
headache diary entries.  Sites will assist subjects with syncing their Scion 
email accounts with their smartphones or tablets, and will ensure that subjects 
can competently take a photo of the ediary form, upload and send according to 
procedure.  If the subject does not complete at least 25 of 28 daily headache 
diary entries during the baseline period, she or he will be withdrawn and will 
not proceed to randomization. 
 
(ii) 
Clinic Training Visit: After enrollment, the completion of one month of daily 
headache diary entries, and reconfirmation by the relevant investigator of the 
subject’s participation in the study, the subject will come to the clinic for an 
appointment(s) for training on the use of the CVS device. During the clinic 
visit, the subject will complete a quality of life (QOL) assessment.  The 
assessment will consist of the HIT-6, BAI, BDI-II and Pittsburgh Sleep 
Quality Assessment questionnaires.  The BAI and BDI-II scores will be tallied 
with the following outcomes: 
 
a. Subjects who score 20 or higher on the BDI-II or answer affirmative to 
questions 9 on the BDI-form will not proceed to randomization and will be 
withdrawn from the study. 
b. Subjects who score 16 or higher on the Beck Anxiety Index will not 
proceed to randomization and will be withdrawn from the study. 
 
(iii) 
Also, women of childbearing age will complete a urine-based pregnancy test to 
reconfirm that they are not pregnant.  The unblinded coordinator will open, at 
random, an envelope assigning the subject to one of the three study arms. The 
clinic period is described below.  During the first visit, the subject will 
complete a training session based on a set training module.  The subject will 
complete a proficiency evaluation and the study coordinator will certify the 
subject’s proficiency in the use of the CVS device. The study coordinator will 

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complete a visit assessment form. At the end of training, a first usability 
questionnaire will be completed by the subject. 
 
(iv) 
First Treatment Period: The eighty-four days (3 months) following the pre-
treatment baseline period constitute the first treatment period.  This is the test 
period, the results from which will be measured against the pre-treatment 
baseline period data in assessing the study endpoints.  Specifically, data from 
the last month of the first treatment period will be compared with the one-
month-long pre-treatment baseline period. As close as possible (as scheduling 
permits) to two weeks after the start of treatment, a clinical visit will occur and 
another visit assessment form will be completed. A second usability 
questionnaire will be completed.  The subject will be asked to bring the CVS 
device to the clinic to perform a treatment in front of the unblinded study 
coordinator to reaffirm proficiency in using the device.  Any issues related to 
balance or other safety concerns will promptly be referred to the site principal 
investigator, who can terminate the subject’s further participation in the study 
if necessary. 
 
(v) 
End of First Treatment Period – Start of Second Treatment Period: At the 
end of the first treatment period the subject will be asked to return to the clinic 
and will be asked to complete the QOL questionnaires and a third usability 
questionnaire.  All subjects will receive new SD cards for the second treatment 
period and the old SD cards will be retained so that treatment compliance logs 
can be extracted.  All subjects will receive active treatment cards with the 
following assignments (first treatment period -> second treatment period): 
 
o BID placebo -> BID active 
o BID active -> BID active 
o QD active -> QD active 
 
Subjects will perform a treatment in front of the unblinded coordinator to re-
confirm their ability to properly use the device. 
 
Note: The treatment delivery data (recorded on the SD cards) from the CVS 
device consists of temperature waveform files that contain actual measured 
temperature values that were delivered to the earpieces during treatments. This 
data is an independent record of the expected device performance and is used 
for confirmation purposes only.  The SD card data files also record treatment 
times and subject compliance, which will be used to calculate the level of 
treatment compliance.  Subjects will not be informed that the device monitors 
treatment compliance. 
 
• End of Second Treatment Period – Start of Observation Period:  At the end of 
the second treatment period, all subjects will return their devices to the clinics.  
The SD cards will be collected.  Subjects will be asked to complete the QOL 
questionnaires again and will be asked to complete a final usability questionnaire.  

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Subjects will then be asked to continue to make recordings in their headache 
diaries for an additional 12 weeks. 
 
• End of Observation Period/End of Study:  Subjects will return to the clinics one 
final time.  They will be asked to complete the QOL questionnaires. 
 
 
5)  Active Treatment Parameters; Placebo Treatments 
 
The following parameters will be set for active treatments using the CVS device: 
• A standardized CVS time-varying waveform lasting approximately 19 minutes 
will be used for all active treatment subjects at all study sites.  Treatments will 
be administered once or twice daily, based upon a subject’s randomization 
assignment.  The two daily treatments should ideally be separated by at least 
one hour. 
• The waveform schedule for active treatment subjects will consist of a warm 
sawtooth delivered to one ear and a cold sawtooth delivered to the other ear.  
The warm sawtooth will go from body temperature to 42 °C, and the cold 
sawtooth will go from body temperature to 17 °C.  The two waveforms will be 
delivered simultaneously, but will have different oscillation frequencies.  After 
each two-day period, the warm and cold waveforms will be switched so that 
the opposite ears will be treated with the different caloric stimulation.  Thus 
every two days the ear receiving the cold stimulus will be switched to the 
warm stimulus and vice versa. 
 
The following parameters will be set for the placebo treatments using the CVS-M 
Device: 
• A standardized CVS waveform lasting approximately 19 minutes will be used 
for all placebo treatment subjects at all study sites.  Treatments will be 
administered twice daily.   
• The waveform schedule for placebo treatment subjects will consist of turning 
on the cooling fans and leaving the earpieces unpowered. 
 
The placebo device will look identical to the Treatment Device and will show, on its 
screen, the identical progress plot shown on the active device.  The y-axis of the plot will 
be labeled “stimulation intensity” and will not list temperature values.  A subject 
receiving a placebo treatment will have the sensation of the earpieces creating some 
pressure in the ear canals and may feel the earpieces warm up to body temperature (the 
metal earpieces will feel cold initially). Placebo subjects will not undergo material caloric 
vestibular stimulation since no temperature gradient will be created across the horizontal 
semicircular canal. The threshold for therapeutic benefit using CVS has not been 
established, but even small temperature changes can result in nystagmus (Sedjawidata et 
al. & Vesterhauge et al.).  The term “CVS” will not be used in describing the device to 
any subject and no reference to caloric stimulation will be made.  The device will be 
referred to as a brainstem neuromodulation device and the specific mechanism of action, 

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that is the use of temperature changes, will not be disclosed to subjects.  Overt focus on 
the CVS phenomenon would create an intractable issue with successful blinding. 
 
All subjects will be told that they may or may not benefit from the Device in terms of 
pain reduction and that, further, the point in the 6-month treatment period at which a 
change may be noticed is unknown and may vary from subject-to-subject – i.e., the 
treatment duration necessary for a potential reduction in pain is unknown for any 
particular individual.  All subjects will be told that they may or may not sense slight 
pressure from the earpieces, a warming or cooling sensation, or slight nausea or 
dizziness, especially at the end of the treatment session, or noise from the device.  At the 
conclusion of each of the two treatment periods, subjects will be asked to identify which 
arm they believe they entered (active treatment or placebo) and why.  Coordinators will 
encourage patients to provide an answer, emphasizing that there are no right or wrong 
answers.  After the very first device treatment (in the clinic), all subjects will be asked a 
series of questions designed to assess the quality of blinding (to provide evidence that the 
placebo device is an effective sham). 
 
6)  Safety 
CVS has been used extensively and safely in the practice of medicine since its discovery 
more than a century ago by Dr. Robert Barany, a discovery for which he received the 
Nobel Prize in Physiology/Medicine in 1914.  There have been no reports in the literature 
of serious adverse events or significant negative side effects associated with diagnostic 
CVS.  In the first RCT, no SAE’s and no unexpected AE’s were reported.  No reductions 
in balance ability, as measured with the Berg balance test, were recorded.  No negative 
changes in mood or cognition were recorded based on the mood and cognition 
assessment battery in that study. 
CVS acts on the central nervous system via the vestibular organs.  This mechanism is 
distinctly different from most forms of neurostimulation that involve either electrical 
currents applied directly to a target nerve or region (implanted neurostimulators) or a 
diffuse current to larger areas of the cortex (TMS, CES, tDCS).  CVS is non-invasive and 
easily employed.  The SNS CVS device enables its therapeutic use and utility by 
controlling thermal induction and providing safeguards that ensure treatments remain 
firmly within parameters established by the supervising physician. 
 
Use of the study device may cause some, all or none of the transient adverse events listed 
below: 
 
More likely:  
• Dizziness 
• Drowsiness 
• Vertigo (whirling or spinning sensation) 
• Discomfort 
 
Less likely: 
• Nausea/vomiting 

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• Headache  
• Coughing 
 
All of these side effects are expected to resolve once use of the device is stopped. 
 
7) Study Endpoints  
 
• Primary Efficacy Endpoint for the Study   
For the twice-per-day active-treatment subjects: During the third month of the 
first treatment period, their average total number of monthly migraine 
headache days will be lower than their comparable averages derived from the 
pre-treatment baseline period. Also, this reduction in migraine headache days 
will exceed that observed in the twice-per-day placebo group. 
 
• Secondary Endpoints: 
o The normalized percent-reduction in migraine headache days (during 
the third treatment month relative to the pre-treatment baseline) in the 
BID active-treatment subjects will be compared to that of the BID 
placebo-treatment subjects.  Groups will be compared on the basis of 
percent-change (continuous variable) as well as the “50% responder 
rates” (discrete variable).  
o The reduction in acute (prescribed) medication taken (during the third 
treatment month relative to the pre-treatment baseline) in the BID 
active-treatment subjects will be compared to that of the BID placebo-
treatment subjects.   
o The reduction in subject-perceived headache pain scores (during the 
third treatment month relative to the pre-treatment baseline) in the BID 
active-treatment subjects will be compared to that of the BID placebo-
treatment subjects.   
o To assess whether active treatment results in improved quality of life 
(related to the reduction in migraine), HIT-6 change scores (end of the 
first treatment period versus baseline) will be compared across BID 
active-treatment subjects and BID placebo-treatment subjects. 
o To assess whether active treatment results in improvements in 
depression or anxiety, BDI and BAI scores (end of the first treatment 
period versus baseline) will be compared across BID active-treatment 
subjects and BID placebo-treatment subjects. 
o To assess whether active treatment results in improved sleep quality, 
Pittsburgh Sleep Quality Assessment change scores (end of the first 
treatment period versus baseline) will be compared across BID active-
treatment subjects and BID placebo-treatment subjects. Correlational 
analysis will be performed to determine whether a relationship exists 
between improved sleep and reduced migraine frequency. 

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o To assess whether BID active treatment provides therapeutic gains 
over QD active treatment, the reductions in migraine headaches, the 
reduction in the number of acute (prescribed) medication taken, the 
reduction in subject-perceived headache pain scores, the normalized 
percent-change in monthly headache days, and the 50% responder 
rates in the BID active-treatment subjects and QD active-treatment 
subjects during the following periods will be compared: the first 
treatment month, the third treatment month, the sixth treatment month 
and the final month of the post-treatment period. Additionally, change 
scores for the QOL measures (HIT-6, BDI, BAI and the Pittsburgh 
Sleep Quality Assessment) at the end of the first and second treatment 
periods and the post-treatment observation period will also be 
assessed.  The response kinetics for each of these parameters will be 
evaluated by comparing time courses for each of the three treatment 
arms.  All change scores will be calculated relative to baseline 
measures. 
o To assess whether six months of active treatment provides improved 
levels of migraine prevention relative to three months of active 
treatment, comparisons of the reductions in migraine headache days, 
the reduction in the number of acute (prescribed) medication taken, the 
reduction in subject-perceived headache pain scores, the normalized 
percent-change in monthly headache days, and the 50% responder 
rates during the third treatment month and the sixth treatment month 
(relative to baseline) for the QD active and the BID active groups will 
be performed.  Change scores for the QOL measures (HIT-6, BDI, 
BAI and the Pittsburgh Sleep Quality Assessment) for the QD active 
and the BID active groups at the end of the first and second treatment 
periods (relative to baseline) will also be compared.  Additionally, 
these measures will also be compared between the BID active and BID 
placebo groups during the sixth treatment month.  All change scores 
will be calculated relative to baseline measures. 
o To assess whether CVS therapy provides durable migraine prevention 
after therapy has ceased, the number of migraine days, the reduction in 
subject-perceived headache pain scores, the number of acute 
(prescribed) medication taken, during each month in the post-Tx 
observation period will be compared to both baseline and the final 
treatment month in all 3 treatment groups.  The normalized percent-
change in monthly headache days and the 50% responder rates 
(relative to baseline) will also be assessed.  Additionally, the QOL 
measurements (HIT-6, BDI, BAI and Pittsburgh Sleep Quality 
Assessment scores) at the final visit will be compared to both the 
baseline and the 6 month scores. 
 
o Measures of body mass index for each subject will be calculated at 
baseline, after three and six months of treatment and after the post-
treatment observation period and compared across the three treatment 

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arms. 
 
o Measures of depression (Beck Depression Inventory) and anxiety 
(Beck Anxiety Inventory) for each subject will be calculated at 
baseline, after three and six months of treatment and after the post-
treatment observation period and compared across the three treatment 
arms. 
 
o To assess whether the reduction in migraine days relates to the number 
of active CVS treatments performed, correlational analyses will be 
performed to assess whether the change in the total number of 
headache days during defined study periods (first treatment period, 
second treatment period and post-treatment observational period) is a 
function of the cumulative CVS treatments performed.  Additionally, 
approaches such as the GLIMMIX procedure for generalized linear 
mixed models will also be performed to determine the probability of a 
headache on any given day is predicted by the cumulative number of 
active treatments performed. 
 
 
As noted above, the baseline period and the first 3-month treatment period 
will constitute a complete RCT.  Those data will be analyzed when the 
targeted number of subjects (120) complete the first treatment period.  
Subjects will continue on to the second 3-month treatment period without 
interruption, as they progress through the study period.  For additional clarity, 
the stated primary endpoint will be evaluated for the baseline period + first 3-
month treatment period. 
  
 
8)  Statistical Analysis and Study Size 
 
An experienced, independent and blinded Statistician will analyze and summarize the 
daily headache diaries for all subjects and evaluate the primary endpoint and 
observational aims.  A blinded reviewer will analyze and summarize the quality of life 
data. 
 
The primary aim of this trial is to determine if subjects randomized to the twice-daily 
active group, have a greater reduction in the number of headache days than those 
assigned to the twice-daily placebo group.  For this study, the reduction in headache days 
(primary endpoint) is calculated as the number of headache days during the baseline 
month minus the number of headache days during treatment month three.  An intent-to-
treat methodology will be employed for the primary aim; however, per protocol analyses 
will also be conducted for comparison.  Analysis of the primary endpoint and the 
secondary headache-related endpoints assessed in the daily diary will be performed for all 
subjects that complete at least 25 diary entries or more during the relevant 28-day 
treatment month.  Treatment compliance is defined as completion of at least 50% during 

14                                      Version 080916  FINAL 
 
each treatment months (for the per protocol evaluation).  Subjects with treatment 
compliance below 50% during any treatment month will be assigned to the intent-to-treat 
group only.  As accurate assessment of some of the secondary endpoints assessed during 
study period do not depend on daily headache diary compliance, treatment compliance 
will be the only criteria for inclusion in the per protocol analysis of those secondary 
outcomes. Statistical significance will be defined with a Type I error of 5% (α=0.05).  
Wilcoxon rank-sum tests (for non-normal data) or a paired student’s t-tests (for normal 
data) will be used to establish whether the reductions in headache days between the 
baseline and third treatment month in each treatment arm are statistically significant.  
Mann-Whitney U tests (for non-normal data) or unpaired student’s t-tests (for normal 
data) will be used to determine whether the reduction in migraine headaches in the twice 
daily active treatment arm subjects is significantly greater than that observed in the twice 
daily placebo treatment arm subjects.  No interim analyses of efficacy are planned.   
 
The study is powered for the primary aim.  Given a sample size of 40 subjects per arm 
and a standard deviation in the reduction of headache days of σ=3.36, a mean difference 
for the reduction in the number of headache days between the twice-daily active arm and 
the twice daily placebo arm of 2.13 days will be detectable at the 95% significance level 
(a=0.05) with 80% power.  The figure below shows the sensitivity of the detectable 
differences relative to the value of the standard deviation and the sample size. 
 
 
 
 
The study is intentionally overpowered for the primary endpoint (based on the mean 
reduction of 2.73 headache days in the first RCT), however, a sample size of 40 subjects 
per arm should allow for sufficient power to assess the majority of secondary endpoints at 
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
30
32
34
36
38
40
42
44
46
48
50
Detectable Difference in the Mean Reduction in the 
Number of Headache Days (Baseline Month - Third Month)
Sample Size per Arm of Study
Power Analysis
95% Significance Level    80% Power
2.13
σ= 3.00
σ= 3.50
σ= 4.00
σ= 3.36
Notes:
1. σ is the standard deviation
2.  RCT1 results showed σ to be 3.36

15                                      Version 080916  FINAL 
 
the end of the sixth treatment month and at the end of the post-treatment observation 
period given the expected dropout rate of 5 subjects per group during each 3 month 
period.  Notably, while the 50% responder rate (a secondary outcome) will be evaluated 
as a discrete variable, it is unlikely to yield statistical significance due to insufficient 
sampling.  Therefore, the similar measure of percent-change in migraine days will also be 
compared as a continuous variable across groups. 
 
An analysis will be conducted to determine if blinding was successful using descriptive 
statistics. 
 
 
9)  Quality Assurance Monitor   
A quality assurance monitor will be used to audit study sites.  Following written 
procedures, the monitor will verify that the clinical trial is conducted and data are 
generated, documented and reported in compliance with the protocol, GCP and 
applicable regulatory requirements. Investigational site(s) will provide direct access to all 
trial related sites, source data/documents and reports for the purpose of monitoring and 
auditing by the sponsor and inspection by regulatory authorities. 
 
10) Procedures for adverse events: 
 
• Documentation and assessment  
o Following the informed consent process, clinical study subjects will be 
routinely questioned about adverse events at study visits and telephone 
contacts by the clinical research sites. All adverse events, regardless of 
treatment group, or suspected causal relationship to the investigational 
device, will be recorded in the subjects’ case report forms in their 
study binder.  
o For all adverse events, sufficient information will be obtained as to 1) 
determine the outcome of the event (i.e., whether the event should be 
classified as “serious”) and; 2) assess the casual relationship between 
the adverse event and the investigational device.  
o Adverse events felt to be associated with the investigational device 
will be followed until the event (or its sequelae) resolves or stabilizes 
at a level acceptable to the investigator and sponsor. 
 
• Causality and severity assessment 
o The investigator will promptly review documented adverse events to 
determine 1) if there is a reasonable possibility that the adverse event 
was caused by the investigational device or other study treatments and 
2) if the adverse event meets the criteria for “serious.” 
o If the Principal Investigator (PI) is not a physician, a sub-investigator 
who is licensed to recognize, diagnose, and treat adverse events (e.g., 
MD) must review this report. The PI, must confirm that an MD sub-
investigator has reviewed and acknowledges the contents of the report 
form. 

16                                      Version 080916  FINAL 
 
o If the investigator’s final determination of causality is “of questionable 
relationship to the investigational device or other study treatments,” 
the adverse effect will be classified as associated with the use of the 
investigational device or other study treatments for reporting purposes.  
If the investigator’s final determination of causality is “not related to 
the 
investigational 
device 
or 
other 
study 
treatments,” 
this 
determination and the rationale for the determination will be 
documented in the respective subject’s case Report form in their study 
binder. 
 
• Reporting adverse events to the responsible IRB 
o Investigators are required to submit a report of a Unanticipated 
Adverse Device Effect (UADE) to the sponsor and the reviewing IRB 
as soon as possible, but in no event later than 10 working days after 
the investigator first learns of the event (21 CFR 812.150(a)(1)). 
However, if the UADE involves a death, it must be reported within 24 
hours of discovery. 
 
• Reporting adverse events to the FDA 
o The sponsor must immediately conduct an evaluation of a UADE and 
must report the results of the evaluation to FDA, all reviewing IRBs, 
and participating investigators within 10 working days after the 
sponsor first receives notice of the event (21 CFR 812.46(b), 
812.150(b)(1)). 
o The UADE must meet all three of the definitions: 1) Adverse Device 
Effect; 2) Serious; and 3) Unanticipated. 
o For any adverse event that is determined to be a UADE, the sponsor 
will submit an expedited safety report to the FDA's Center for Devices 
and Radiological Health.  The expedited safety report will consist of: 
§ a completed Form FDA 3500A  
§ a cover letter analyzing the significance of the event   
o A copy of this safety report and the results of such report will be 
provided to all participating study investigators and reviewing IRBs. 
o The completed Form FDA 3500A and cover letter will be submitted to 
the FDA as soon as possible and, in no event, later than 10 working 
days after the sponsor first receives notice of the UADE. 
o If, following receipt and investigation of follow-up information 
regarding an adverse event that was previously determined not to be a 
UADE, the sponsor-investigator determines that the event does meet 
the requirements for expedited reporting, the sponsor-investigator will 
submit a completed Form FDA 3500A and cover letter as soon as 
possible, but in no event later than 10 working days, after the 
determination is made. 
o Subsequent to the initial submission of a completed FDA Form 
3500A, the sponsor will submit additional information concerning the 
reported adverse event as requested by the FDA. 

17                                      Version 080916  FINAL 
 
 
• Procedure in the event of a mood abnormality post-randomization: BDI-
II scores above 20 or BAI scores above 16 after treatment has commenced 
should be referred to the PI for consultation.  If the subject answers in the 
affirmative to question 9 of the BDI-II form, he/she should be referred for 
mental health counseling on that same clinic visit. 
 
• Withdrawal of consent due to AE 
o If a subject withdraws consent due to an AE or if the PI determines the 
subject should be withdrawn due to an AE deemed to be possibly 
related to use of the device, the details of that event should be noted on 
the subject disposition form.  Additional, study sites should follow up 
with the subject so as to document the resolution of the AE. 
 
 
 
 
 
 
11)  References:  
ICDH-2: (2004). "The International Classification of Headache Disorders: 2nd edition." 
Cephalalgia 24 Suppl 1: 9-160. 
 
ICDH-3 beta: (2013). “The International Classification of Headache Disorders, 
3rd edition (beta version).” Cephalalgia 33(9): 629-808. 
 
Sedjawidada, R., D. Mangape, et al. (1995). "Minimum amount of calories needed to elicit the 
vestibulo-ocular reflex in normal human subjects." Acta Otolaryngol Suppl 519: 17-20. 
 
Tfelt-Hansen, P., J. Pascual, et al. (2012). "Guidelines for controlled trials of drugs in migraine: 
third edition. A guide for investigators." Cephalalgia 32(1): 6-38. 
 
Vesterhauge, S., S. Holm-Jensen, et al. (1984). "Caloric testing with small temperature gradients. 
Caloric zero." ORL J Otorhinolaryngol Relat Spec 46(2): 105-110. 
 
 
 

18                                      Version 080916  FINAL 
 
Definitions 
• Generally, International Headache Society (IHS) definitions, 
including the definition of migraine headache and episodic migraine 
headache, will be used in planning and conducting the Study.  The 
summary in Tfelt-Hansen et al. for prophylactic migraine studies 
serves as the principal reference. 
• Adverse Event (AE) shall mean any untoward medical occurrence 
in a subject that may or may not be related to the investigational 
product or have a causal relationship with the investigational 
treatment. An AE can therefore be any unfavorable and unintended 
sign, symptom, or disease temporally associated with the 
investigational product. 
• Adverse Device Effect (ADE) shall mean any device related 
adverse event. 
• CVS means caloric vestibular stimulation. 
• CVS device shall mean the Scion NeuroStim, solid-state CVS 
treatment unit (for Investigational Use Only). 
• Daily Headache Diary shall mean recordings of relevant headache 
and other study information by each subject on a daily basis using 
the specified procedure.  Each day, subjects will complete a form 
documenting whether they experienced a headache, whether they 
thought their headache was a migraine, what their maximum 
headache pain score has been, the headache duration, associated 
symptoms, medications taken and occurrence of any side effects.  
Subjects will submit electronic images of these forms using their 
Scion associated emails.  The daily headache diary will be the 
principal instrument for assessing the primary endpoint.  
• Headache shall mean a pain located within the subject’s head when 
the subject assigns to it a pain score between one and ten on the 
headache pain scale. 
• Headache Day shall mean a day during which the subject has a 
Headache. 
• Headache-Free Day shall mean a day on which the subject does not 
have a headache – that is, a day when the subject has a headache 
pain score of zero. 
• Headache History Questionnaire shall mean a listing of subject 
history elements relevant to the assessment of her or his migraine 
headache status. 
• Headache Pain Scale shall mean an eleven-point pain measurement 
scale from zero (no pain) to ten (most intense pain).  The pain data 
will also be mapped onto a four-point (0 – 3) scale and to a 
description based on “mild/moderate/severe” categories to facilitate 
placing this study in the context of other prophylactic pain studies. 
Subjects will be trained on the scale shown below in order to rank 
their pain on the 11-point scale: 

19                                      Version 080916  FINAL 
 
 
Pain scores can be mapped a 4-point scale as well (0-3), with which 
some subjects may be more familiar, where the transformation shall 
be achieved in accord with the graph below: 
 
 
• Investigators: Sites and Investigators are listed on a separate roster. 
 
• Migraine Headache In terms of diagnosis shall mean (following the 
ICDH-II guidelines) a headache that lasts at least four hours, reaches 
a pain score of at least four on the headache pain scale (moderate or 
severe), is not attributed to another disorder and has at least two of 
the following characteristics from A and at least one of the 
characteristics from B, respectively: 
o A:  (1) unilateral location; (2) pulsating quality; (3) moderate 
or severe pain intensity; (4) aggravation by or causing 
avoidance of routine physical activity (e.g., walking or 

20                                      Version 080916  FINAL 
 
climbing stairs); 
o B: During headache: (1) nausea and/or vomiting; (2) 
photophobia and phonophobia;  
 
For the purpose of the study, headaches will be classified using the 
subject’s own judgment.  Subjects will receive instructions on how 
to differentiate a migraine headache from a non-migrainous 
headache.  Treated headaches using acute (prescribed) abortive 
medications will be considered to be migraine headaches.  
 
• Migraine Headache Day shall mean any calendar day during which 
a subject had a migraine headache of at least 30-minutes in duration.  
• Month or Monthly shall mean or refer to a period of twenty-eight 
days, usually consecutive in timing. 
• Pain Score shall mean a maximal pain rating made by a subject for 
an individual headache or for a headache-free day based on using the 
headache pain scale (zero to ten).   
• Study shall mean this SNS-sponsored, multi-site, randomized, triple-
blinded, placebo-controlled, episodic migraine clinical study.  
• Pre-Treatment Baseline Period shall mean, with respect to each 
study participant, the first month (i.e., twenty-eight days) of the 
study period. 
• Pre-Treatment History: the established migraine headache history 
of that participant. 
• Quality of Life Assessments will consist of: 
o HIT-6: a common QOL measure used in migraine prevention 
studies. 
o BAI: the Beck Anxiety Index.  The following ranges are 
established: 
§ 0-7     minimal 
§ 8-15   mild 
§ 16-25 moderate 
§ 26-63 severe 
o BDI-II: the Beck Depression Index.  The following ranges 
are established: 
§ 0-13   minimal 
§ 14-19 mild 
§ 20-28 moderate 
§ 29-63 severe 
o Pittsburg Sleep Quality Assessment: An established test 
protocol to assess sleep latency and quality. 
• Serious Adverse Event (SAE): an adverse event or suspected 
adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: 
1) Death; 2) a life-threatening adverse event; 3) inpatient 
hospitalization or prolongation of existing hospitalization; 4) a 

21                                      Version 080916  FINAL 
 
persistent or significant incapacity or disability; 5) or a congenital 
anomaly/birth defect. Important medical events that may not result in 
death, be life-threatening, or require hospitalization may be 
considered serious when, based upon appropriate medical judgment, 
they may jeopardize the patient or subject and may require medical 
or surgical intervention to prevent one of the outcomes listed in this 
definition. 
• SNS: Scion NeuroStim, LLC, the study sponsor. 
• Treated Headache: A migraine headache lasting at least 30 minutes 
for which a subject takes an acute abortive migraine medication 
(prescription medication, not OTC). 
• Unanticipated: Not previously identified in nature, severity, or 
degree of incidence in the investigational plan (protocol) or 
Investigational Brochure/Device Manual. 
• Unanticipated Adverse Device Effect (UADE): any serious 
adverse effect on health or safety or any life-threatening problem or 
death caused by, or associated with, a device, if that effect, problem, 
or death was not previously identified in nature, severity, or degree 
of incidence in the investigational plan (protocol), or is not listed at 
the specificity or severity that has been observed; or any other 
unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
  

Name: _ 
Marital Status: 
Age: _ 
Occupation: 
Education: 
 
 
 
 
_ 
 
_ 
__  Sex:   
 
  
_ 
_ 
 
Instructions:   This questionnaire consists of 21 groups of statements. Please read each group of statements carefully, and 
then pick out the one statement in each group that best describes the way you have been feeling during the past two 
weeks, including today. Circle the number beside the statement you have picked . If several statements in the group 
seem to apply equally well , circle the highest number for that group. Be sure that you do not choose more than one 
statement for any group, including Item 16 (Changes in Sleeping Pattern) or Item 18 (Changes in Appetite). 
 
1. Sadness 
0 
I do not feel sad. 
1 
I feel sad much of the time. 
2 
I am sad all the time. 
3 
I am so sad or unhappy that I can't stand it. 
 
2. Pessimism 
0 
I am not discouraged about my future. 
1 
I feel more discouraged about my future than I 
used to be. 
2 
I do not expect things to work out for me. 
3 
I feel my future is hopeless and will only 
get worse. 
 
3. Past Failure 
0 
I do not feel like a failure. 
I have failed more than I should have. 
2 
As I look back, I see a lot of failures. 
3 
I feel I am a total failure as a person . 
 
4. Loss of Pleasure 
0 
 I get as much pleasure as I ever did from the 
things I enjoy. 
1 
I don't enjoy things as much as I used to. 
2 
I get very little pleasure from the things I used 
to enjoy. 
3 
I can't get any pleasure from the things I used 
to enjoy. 
 
5. Guilty Feelings 
0 
I don't feel particularly  guilty. 
I feel guilty over many things I have done or 
should have done. 
2 
I feel quite guilty most of the time. 
3 
I feel guilty all of the time. 
6. Punishment Feelings 
0 
I don't feel I am being punished. 
I feel I may be punished . 
2 
I expect to be punished . 
3 
I feel I am being punished. 
 
7. Self-Dislike 
0 
I feel the same about myself as ever. 
I have lost confidence in myself. 
2 
I am disappointed in myself. 
3 
I dislike myself. 
 
8. Self-Criticalness 
0 
I don't criticize or blame myself more than usual. 
I am more critical of myself than I used to be. 
2 
I criticize myself for all of my faults. 
3 
I blame myself for everything bad that happens. 
 
9. Suicidal Thoughts or Wishes 
0 
I don't have any thoughts of killing myself. 
I have thoughts of killing myself, but I would 
not carry them out. 
2 
I would like to kill myself. 
3 
I would kill myself if I had the chance. 
 
10. Crying 
0 
I don 't cry any more than I used to. 
I cry more than I used to. 
2 
I cry over every little thing. 
3 
I feel like crying, but I can't. 
 
 
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Subtotal Page  1 
 
Copyright © 1996 Aaron T. Beck. All rights reserved. 
Printed in the United States of America. 
 
 
@ PsychCorp 
27 28 29 30
B C D E
281283-1
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Product Number 0154018392
patient ID 

11. Agitation 
0 
I am no more restless or wound up than usual. 
1 
I feel more restless or wound up than usual. 
2 
I am so restless or agitated that it's hard to stay 
still. 
3 
I am so restless or agitated that I have to keep 
moving or doing something. 
12. Loss of Interest 
0 
I have not lost interest in other people or 
activities. 
1 
I am less interested in other people or things 
than before. 
2 
I have lost most of my interest in other people 
or things. 
3 
It's hard to get interested in anything. 
13. Indecisiveness 
0 
I make decisions about as well as ever. 
1 
I find it more difficult to make decisions than 
usual. 
2 
I have much greater difficulty in making 
decisions than I used to. 
3 
I have trouble making any decisions. 
14. Worthlessness 
0 
I do not feel I am worthless. 
1 
I don't consider myself as worthwhile and useful 
as I used to. 
2 
I feel more worthless as compared to other 
people. 
3 
I feel utterly worthless. 
15. Loss of Energy 
0 
I have as much energy as ever. 
1 
I have less energy than I used to have. 
2 
I don't have enough energy to do very much. 
3 
I don't have enough energy to do anything. 
16. Changes in Sleeping Pattern 
0 
I have not experienced any change in my 
sleeping pattern. 
l a   I sleep somewhat more than usual. 
1b  I sleep somewhat less than usual. 
2a  I sleep a lot more than usual. 
2b  I sleep a lot less than usual. 
3a  I sleep most of the day. 
3b  I wake up 1-2 hours early and can't get back 
to sleep. 
17. Irritability 
0 
I am no more irritable than usual. 
1 
I am more irritable than usual. 
2 
I am much more irritable than usual. 
3 
I am irritable all the time. 
 
18. Changes in Appetite 
0 
I have not experienced any change in my 
appetite. 
l a  My appetite is somewhat less than usual. 
1b  My appetite is somewhat greater than usual. 
2a  My appetite is much less than before. 
2b  My appetite is much greater than usual. 
3a  I have no appetite at all. 
3b  I crave food all the time. 
 
19. Concentration  Difficulty 
0 
I can concentrate as well as ever. 
1 
I can't concentrate as well as usual. 
2 
It's hard to keep my mind on anything for 
very long. 
3 
I find I can't concentrate on anything. 
 
20. Tiredness or Fatigue 
0 
I am no more tired or fatigued than usual. 
1 
I get more tired or fatigued more easily than 
usual. 
2 
I am too tired or fatigued to do a lot of the things 
I used to do. 
3 
I am too tired or fatigued to do most of the 
things I used to do. 
 
21. Loss of Interest in Sex 
0 
I have not noticed any recent change in my 
interest in sex. 
I am less interested in sex than I used to be. 
2 
I am much less interested in sex now. 
3 
I have lost interest in sex completely. 
NOTICE: This form is printed with blue and black ink. If your 
copy does not appear this way, it has been photocopied in 
violation of copyright laws. 
  
  Subtotal Page 2 
  
  Subtotal Page I 
T
l S

NAM E 
 
 
DATE     
 
Below is a list of common symptoms of anxiety. Please carefully read each item in the list. Indicate how much you have been bothered by each 
symptom during the PAST WEEK , INCLUDING TODAY , by placing an X in the corresponding space in the column next to each symptom. 
 
 
 
MILDLY 
MODERATELY 
SEVERELY 
 
 
 
1. Numbness or tingling. 
 
2. Feeling hot. 
 
3. Wobbliness in legs. 
 
4. Unable to relax. 
 
5. Fear of the worst happening. 
 
6. Dizzy or lightheaded. 
 
7. Heart pounding or racing. 
 
8. Unsteady. 
 
9. Terrified. 
 
10. Nervous. 
 
11. Feelings of choking. 
 
12. Hands trembling. 
 
13. Shaky. 
 
14. Fear of losing control. 
 
15. Difficulty breathing. 
 
16. Fear of dying. 
 
17. Scared. 
 
18. Indigestion or discomfort in abdomen. 
 
19. Faint. 
 
20. Face flushed . 
 
21. Sweating (not due to heat). 
-
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P.O. Box  599700    5an  Antonio,  TX  78259    800.627.7271    www.PsychCorp.com 
@ PsychCorp 
Copyright ©  1990, 1987 by Aaron T.  Beck. All rights reserved. Published and distributed exclusively by NCS Pea rson, 
Warning: No part of this publication may be reproduced or transmitted in any form or by any means, electronic or 
Inc. 
mechanical, including photocopy, recording, or any information storage and retrieval system, without permission in writing 
from  the copyright owner.  BAI,  Pearson,  the  PSI  logo,  and  PsychCorp  are trademark s in the  U.S. and/or other countries 
of  Pearson  Education, Inc.,  or  its affiliate(s). 
45 46 47 48 49 50 A B C D E 
281553-1 
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Product Number 0154018422 
patient ID 

Name: 
Date:  
 
 
Please circle the response that best describes how you feel 
and calculate the totals below. 
1. When you have headaches, how often is the pain severe? 
 
A) Never 
B)  Rarely 
C)  Sometimes 
D)  Very Often 
E)  Always 
 
2. How often do headaches limit your ability to do usual daily activities including 
household work, work, school, or social activities? 
 
A) Never 
B)  Rarely 
C)  Sometimes 
D)  Very Often 
E)  Always 
 
3. When your have a headache, how often do you wish you could lie down? 
 
A) Never 
B)  Rarely 
C)  Sometimes 
D)  Very Often 
E)  Always 
 
4. In the past 4 weeks, how often have you felt too tired to do work or daily activities 
because of your headaches? 
 
A) Never 
B)  Rarely 
C)  Sometimes 
D)  Very Often 
E)  Always 
 
5. In the past 4 weeks, how often have you felt fed up or irritated because of your 
headaches? 
 
A) Never 
B)  Rarely 
C)  Sometimes 
D)  Very Often 
E)  Always 
 
6. In the past 4 weeks, how often did headaches limit your ability to concentrate on 
work or daily activities? 
 
A) Never 
B)  Rarely 
C)  Sometimes 
D)  Very Often 
E)  Always 
 
 
 
 
 
 
# of A’s 
# of B’s 
# of C’s 
# of D’s 
# of E’s 
 
 
 
 
 
 
Multiply by 
6 points each 
Multiply by 
8 points each 
Multiply by 
10 points each 
Multiply by 
11 points each 
Multiply by 
13 points each 
 
 
 
 
HIT-6 score 
 
 
 
Bonus Questions 
On a scale of 0-10, with “10” being the worst discomfort imaginable above the shoulders, and a “0” is no 
pain at all (you feel fabulous), how many mornings per week do you wake with a “0”, that is, you feel fabulous?  
 
On those mornings that you wake “with a number”, what’s the average number that you have? 

HEADACHE 
IMPACT TESTTM 
What Does Your Score Mean? 
 
 
 
If You Scored 60 or More 
Your headaches are having a very severe impact on your life. You may be experiencing disabling pain and other symptoms that 
are more severe than those of other headache sufferers. Don’t let your headaches stop you from enjoying the important things in 
your life, like family, work, school or social activities. 
 
Make an appointment today to discuss your HIT-6 results and your headaches with your doctor. 
 
If You Scored 56 – 59 
Your headaches are having a substantial impact on your life. As a result you may be experiencing severe pain and other 
symptoms, causing you to miss some time from family, work, school, or social activities. 
 
Make an appointment today to discuss your HIT-6 results and your headaches with your doctor. 
 
If You Scored 50 – 55 
Your headaches seem to be having some impact on your life. Your headaches should not make you miss time from family, 
work, school, or social activities. 
 
Make sure you discuss your HIT-6 results and your headaches at your next appointment with your doctor. 
 
If You Scored 49 or Less 
Your headaches seem to be having little to no impact on your life at this time. We encourage you to take HIT-6 monthly to 
continue to track how your headaches affect your life. 
 
 
If Your Score on HIT-6 is 50 or Higher 
You should share the results with your doctor. Headaches that are disrupting your life could be migraine. 
 
Take HIT-6 with you when you visit your doctor because research shows that when doctors understand exactly how badly 
headaches affect the lives of their patients, they are much more likely to provide a successful treatment program, which may 
include medication. 
 
HIT is also available on the Internet at www.headachetest.com. 
 
The Internet version allows you to print out a personal report of your results as well as a special detailed version for your doctor. 
Don’t forget to take HIT-6 again or try the Internet version to continue to monitor your progress. 
About HIT 
The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on your ability to function on the job, at 
school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your 
ability to function. HIT was developed by an international team of headache experts from neurology and primary care medicine 
in collaboration with the psychometricians who developed the SF-36→* health assessment tool. 
 
HIT is not intended to offer medical advice regarding medical diagnosis or treatment. You should talk to your healthcare 
provider for advice specific to your situation. 
 
SF-36→ is a registered trademark of Medical Outcomes Trust and John E. Ware, Jr. 
 
HIT-6 Scoring Interpretation English Version 1.1 
©2001 QualityMetric, Inc. and GlaxoSmithKline Group of Companies. All rights reserved. 

Name  
 
Sleep Quality Assessment 
(PSQI) 
What is PSQI, and what is it measuring? 
Date  
 
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It 
differentiates “poor” from “good” sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep 
duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. 
INSTRUCTIONS: 
The following questions relate to your usual sleep habits during the past month only. Your answers should indicate the most 
accurate reply for the majority of days and nights in the past month. Please answer all questions. 
During the past month, 
1. 
When have you usually gone to bed? 
2. 
How long (in minutes) has it taken you to fall asleep each night? 
  
 
3. 
What time have you usually gotten up in the morning? 
4. 
A. How many hours of actual sleep did you get at night? 
B. How many hours were you in bed? 
 
5. During the past month, how often have you had trouble sleeping because you 
Not during 
the past 
month (0) 
Less than 
once a week 
(1) 
Once or 
twice a 
week (2) 
Three or more 
times a week 
(3) 
A. Cannot get to sleep within 30 minutes 
B. Wake up in the middle of the night or early morning 
C. Have to get up to use the bathroom 
D. Cannot breathe comfortably 
E. Cough or snore loudly 
F. Feel too cold 
G. Feel too hot 
H. Have bad dreams 
I. Have pain 
J. Other reason (s), please describe, including how often you have had trouble sleeping because of this reason (s): 
6. During the past month, how often have you taken medicine (prescribed or “over the  counter”) to help you sleep? 
7. During the past month, how often have you had trouble staying awake while driving, eating meals, or engaging in 
social activity? 
8. During the past month, how much of a problem has it been for you to keep up enthusiasm to get things done? 
9. During the past month, how would you rate your sleep quality overall? 
Very good 
(0) 
Fairly good 
(1) 
Fairly bad 
(2) 
Very bad (3) 
Scoring 
Component 1 
#9 Score 
C1   
 
Component 2 
#2 Score (<15min (0), 16-30min (1), 31-60 min (2), >60min (3)) 
 
+ #5a Score (if sum is equal 0=0; 1-2=1; 3-4=2; 5-6=3) 
C2   
 
Component 3 
#4 Score (>7(0), 6-7 (1), 5-6 (2), <5 (3) 
C3   
 
Component 4 
(total # of hours asleep) / (total # of hours in bed) x 100 
 
>85%=0, 75%-84%=!, 65%-74%=2, <65%=3 
C4   
 
Component 5 
# sum of scores 5b to 5j (0=0; 1-9=1; 10-18=2; 19-27=3) 
C5   
 
Component 6 
#6 Score 
C6   
 
Component 7 
#7 Score + #8 score (0=0; 1-2=1; 3-4=2; 5-6=3) 
C7   
 
Add the seven component scores together   
 
Global PSQI    
 

A total score of “5” or greater is indicative of poor sleep quality. 
If you scored “5” or more it is suggested that you discuss your sleep habits with a 
healthcare provider 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
SCREENING VIST (Visit 1) 
Informed Consent Process 
Yes 
No 
1.   Is the subject able to read and understand the informed consent form? 
 
 
2.   Has a thorough review and discussion of the study been conducted with the 
subject? 
 
 
3.   Has the subject had an opportunity to ask questions and have those questions 
answered? 
 
 
4.   Did the subject sign/date the informed consent prior to any study procedures 
being done? 
 
 
5.   Has a copy of the signed consent been given to the subject? 
 
 
ICF Version/Date: 
 
Signature (of person obtaining informed consent): 
Date:  
 
 
Inclusion Criteria: Each participant must have a pre-treatment history that, 
when initially screened by a principal investigator or designee, documents that 
she/he meets all elements of the following: 
 
 
 
Yes 
No 
• 
The patient must have been diagnosed with episodic migraine headache at 
least six months prior to entering into the Study, consistent with the 
International Headache Classification of Headache Disorders-II (ICHD-II) 
guidelines. 
 
 
• 
The patient must have a history of at least three consecutive months of stable 
migraine headaches prior to entering the study. The patients will not have had 
changes in medication usage for the three months leading up to the study, nor 
will they introduce new medications during the study period. Patients  will 
satisfy these criteria: On a monthly basis, at least four, and not more than a 
total of fourteen (4-14), headache days of which between four and fourteen (4- 
14) are migraine headache days, as judged by the patient. 
 
 
• 
The patient must not have failed on more than two classes of properly 
administered prophylactic pharmaceutical therapies for migraine headache.  
The patient may be on a single migraine prophylactic drug as long as the dosage 
has not been altered within three months of starting the study and the dosage 
must not be altered for the duration of the study. 
 
 
• 
The Investigator must have confidence in the patient's ability to reliably use the 
CVS device and promptly complete the electronic daily headache diary forms. 
The daily headache diary will be completed from the beginning of the pre- 
treatment baseline period through the end of the study. The diary is described 
more fully below and in the definitions section at the end of this document. 
 
 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Exclusion Criteria Individuals who: 
Yes 
No 
• 
have previously participated in a clinical trial using the TNM Device 
 
 
• 
are pregnant 
 
 
• 
have a history of cardiovascular disease 
 
 
• 
work night shifts 
 
 
• 
have been diagnosed with vestibular migraine 
 
 
• 
have menstrual migraine exclusively 
 
 
• 
have been diagnosed with post-traumatic migraine 
 
 
• 
have a history of unstable mood disorder or unstable anxiety disorder 
 
 
• 
use a hearing aid 
 
 
• 
have a cochlear implant 
 
 
• 
have chronic tinnitus 
 
 
• 
have temporomandibular joint disease 
 
 
• 
have been diagnosed with traumatic brain injury 
 
 
• 
have been diagnosed with neurological disease other than headaches 
 
 
• 
have a diagnosed vestibular dysfunction 
 
 
• 
abuse alcohol or other drugs 
 
 
• 
are experiencing medication overuse headaches (individuals with respect to 
whom the principal investigator is concerned that analgesic abuse is involved 
based on the ICHD-II guidelines). 
 
 
• 
are less than 18 years old or greater than 65 years old 
 
 
• 
have had eye surgery within the previous three months or ear surgery within 
the previous six months 
 
 
• 
have active ear infections or a perforated tympanic membrane 
 
 
• 
have participated in another clinical trial within the last 30 days or are currently 
enrolled in another clinical trial 
 
 
• 
are using Botulinum toxin-based treatments for migraines 
 
 
• 
are taking anti-emetics chronically 
 
 
 
Please Note: Though not excluded, patients taking anti-histamines will be encouraged not to take such 
medications within four (4) hours prior to a CVS treatment. The investigator should review other 
medications taken by the patient with properties that mimic anti-nausea or anti-dizziness drugs as these 
may reduce responsiveness of the vestibular system to caloric stimulation. Such medications should  
also be avoided within four (4) hours prior to a CVS treatment. 
 
Demographics: 
Complete or Circle 
Date of Birth:  (dd/mmm/yyyy) 
  
/ 
/  
 
Gender: 
Male 
Female 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
 
SUBJECT ID:  
 
DATE:   
  
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Headache History Questionnaire  
Complete or Circle 
Date of Diagnosis (Episodic migraine): 
dd/mmm/yyyy 
  
/ 
/  
 
Monthly Total of all Headache Days (including migraines): 
 
 
Of those, Monthly Total of Migraine Days (only migraines): 
 
 
Did you have an accident or injury that may have started your headaches? 
YES 
NO 
Are your headaches attributed to another disorder? 
YES 
NO 
Do you have any warnings/symptoms of a headache for a period of time 
before the headache begins? 
YES 
NO 
Please describe the severity of your headaches: 
Mild 
Moderate 
Severe 
 
When you have a headache: 
Yes 
No 
Activity/Exercise makes it worse 
 
 
Bright lights bother you 
 
 
Loud sounds bother you 
 
 
Like to stay in a quiet, dark room and try to fall asleep 
 
 
Have nausea and/or vomiting 
 
 
Feel lightheaded or dizzy 
 
 
Certain odors bother you 
 
 
 
My headaches are often brought on by: 
Yes 
No 
Fatigue 
 
 
Lying down 
 
 
Chewing 
 
 
Talking 
 
 
Certain Foods 
 
 
Stress/Tension 
 
 
Stooping 
 
 
Certain Medications 
 
 
Menstruation 
 
 
Alcohol 
 
 
Oversleeping 
 
 
Washing face 
 
 
Coughing 
 
 
Shaving 
 
 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Family History (blood relatives that have severe headaches): Check all that apply 
 
 
Social History: 
Yes  No 
Do you smoke? 
 
 
If so, how much? 
How often?   
 
Do you drink alcohol? 
 
 
If so, how much? 
How often?   
 
Do you use caffeine? 
 
 
If so, how much? 
How often?   
 
 
Prophylactic Migraine Medications: What medications do you take currently (“C”) 
or have you taken in the past (“P”) for your headaches? Chose all that apply 
Amitriptyline (Elavil) 
 
Nortriptyline 
 
Propranolol (Inderal) 
 
SOMA 
 
Flexeril 
 
Topamax 
 
Timolol 
 
Corgard (Nadolol) 
 
Lamictal 
 
Neurontin 
 
Depakote 
 
Remeron 
 
Lyrica 
 
Serzone 
 
Lexapro 
 
Zoloft 
 
Celexa 
 
Wellbutrin 
 
Cymbalta 
 
Paxil 
 
Zyprexa 
 
Clonidine 
 
Effexor 
 
Prednisone 
 
Seroquel 
 
Zanaflex 
 
 
Lithium 
 
Doxepin 
 
 
 
Allergic Reactions to Food/Drugs: (Please list) 
 
 
 
 
 
 
 
 
 
Concomitant Medications: 
 
  
Mother 
Father 
Sister 
 Brother 
None 
Unknown 
Maternal (Mother’s side): 
Aunt 
Uncle 
Grandparent Cousin 
Paternal (Father’s side): 
Aunt 
Uncle 
Grandparent Cousin 
The use of acute abortive medications for the symptomatic treatment of migraine headache will be 
allowed during the clinical trial. Subjects may use their usual acute abortive medications, and 
medications should not be changed during the clinical trial. A treated migraine headache is one for 
which a subject has taken an acute abortive medication (prescription medication, not OTC). The 
subject may be on a single migraine prophylactic drug as long as the dosage has not been altered 
within three months of starting the study and the dosage must not be altered for the duration of the 
study. The subject must not have failed on more than two classes of properly administered 
prophylactic pharmaceutical therapies for migraine headache. Prophylactic medications used to treat 
other medical conditions may be used, at the principal investigator's discretion, if the subject is taking 
a stable dose for at least three months prior to screening and continues throughout the study. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Concomitant Medications: (Rx and OTC) 
Medication 
Dose 
Route 
Frequency 
Start 
Date 
Stop 
Date 
Indication Was med 
taken for 
AE? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Medical History Form 
 
Medical History 
Onset Date 
Resolution Date (or Ongoing) 
Episodic Migraines 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
 
Ear Exam: Observations and check for presence of cerumen (recommend cleaning procedure as 
needed). 
_ 
_ 
 
 
 
 
Physician Signature (for ear exam): 
_Date: 
_ 
 
Screening Results: 
Yes 
No 
Did the subject satisfy all study entry criteria at Screening Visit? 
 
 
If No, please complete Subject Disposition Form. Subject is a Screen Failure. 
 
 
 
 
Study Coordinator: I have verified that the subject has shown competence in filling out the Daily 
Headache Diary and using the gmail account to upload the Daily Headache Diary. I have confirmed with 
the subject that he/she will contact me regarding any future questions about proper diary recordation 
methods, should they arise. 
 
 
 
 
 
Study Coordinator Signature 
Date 
 
 
 
I have reviewed the data from this visit and found the information to be complete and 
accurate.  I verify that all of the tasks have been performed. 
 
 
 
 
 
 
Principal Investigator Signature 
Date 
• Dispense Daily Headache Diary to subject. 
• Train subject on completing the Daily Headache Diary. 
• Assign gmail account to subject with their Subject ID. 
• Train subject on how to use the gmail account to upload Daily Headache Diary. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Treatment Day 1 (Visit 2) 
Baseline Daily Headache Diary: 
Yes 
No 
Does the subject have on a monthly basis, at least four, and not more than a total of 
fourteen (4-14), headache days of which between four and fourteen (4-14) are 
migraine headache days, as judged by the subject. 
 
 
If Yes, please proceed with Treatment Day 1 Visit procedures. If No, please conclude the visit, and 
complete the Subject Disposition Form. Subject is a Screen Failure. 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Vital Signs: 
Height: 
  
   cm   / inches (circle one) 
Weight: 
  
 
kg   /  lbs 
(circle one) 
 
Urine Pregnancy Test Results: 
Positive 
Negative  N/A 
Name: 
Lot #: 
Exp. Date: 
 
 
 
Ear Exam: Observations and check for presence of cerumen (recommend cleaning procedure as 
needed). 
_ 
_ 
 
 
 
 
Physician Signature (for ear exam): 
_Date: 
_ 
 
Quality of Life Assessments: 
Yes 
No 
Scores 
Hit-6 Questionnaire (completed) 
 
Pittsburgh Sleep Quality Assessment (completed) 
 
BDI-II (completed) 
 
BAI (completed) 
 
A BDI-II score of 20 or greater and/or a BAI score of 16 or greater will disqualify a patient from 
randomizing into the treatment portion of the study. 
 
Randomization: 
Yes 
No 
Does the subject met all eligibility criteria for randomization? 
 
 
If Yes, please proceed with Device Treatment Training. If No, please conclude the visit, and 
complete the Subject Disposition Form. Subject is a Screen Failure. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Device Treatment at the Clinical Site: 
Yes 
No 
Any side effects or AEs reported after device treatment? 
 
 
Was the device treatment aborted? 
 
 
Any complaints from subject? 
 
 
Any concerns about the subject? 
 
 
If Yes, to any questions above, please provide comment: 
 
 
 
 
 
Study Coordinator: I verify that the subject has received training and has shown competence in using the 
TNM Device. I believe that the subject will be able to complete device treatments in the home setting. I 
have confirmed with the subject that he/she will contact me regarding any future questions regarding safe 
use of the TNM device, should they arise. 
 
 
 
 
 
Study Coordinator Signature 
Date 
 
 
 
I have reviewed the data from this visit and found the information to be complete and 
accurate.  I verify that all of the tasks have been performed. 
 
 
 
 
 
 
Principal Investigator Signature 
Date 
• 
Dispense TNM Device to subject. 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Administer Usability Questionnaire after completion of device training. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
Clinic Visit Day 14 (Visit 3) 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Ear Exam: Observations and check for presence of cerumen (recommend cleaning procedure as 
needed). 
_ 
_ 
 
 
 
 
Physician Signature (for ear exam): 
_Date: 
_ 
 
Vital Signs: 
Height: 
  
   cm   / inches 
Weight: 
  
 
kg   /  lbs 
 
Device Treatment at the Clinical Site: 
Yes 
No 
Any side effects or AEs reported after device treatment? 
 
 
Was the device treatment aborted? 
 
 
Any complaints from subject? 
 
 
Any concerns about the subject? 
 
 
If Yes, to any questions above, please provide comment: 
 
 
 
 
I have reviewed the data from this visit and found the information to be complete and 
accurate.  I verify that all of the tasks have been performed. 
 
 
 
 
 
Principal Investigator Signature 
Date 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Administer Usability Questionnaire after completion of device training. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 

Study Coordinator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 9) 
 
A phone call to the subject is required every 2 weeks after Clinic Visit Day 14 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with daily device treatments? 
 
 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to any questions above, please provide comment: 
 
 
Date of this phone contact 
/ 
/_  
 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Study Coordinator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 11) 
 
A phone call to the subject is required every 2 weeks after Clinic Visit Day 14 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with daily device treatments? 
 
 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to any questions above, please provide comment: 
 
 
Date of this phone contact 
/ 
/_  
 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Study Coordinator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 13) 
 
A phone call to the subject is required every 2 weeks after Clinic Visit Day 14 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with daily device treatments? 
 
 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to any questions above, please provide comment: 
 
 
Date of this phone contact 
/ 
/_  
 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
 
SUBJECT ID:  
  
DATE:   
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 15) 
 
A phone call to the subject is required every 2 weeks after Clinic Visit Day 14 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with daily device treatments? 
 
 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to any questions above, please provide comment: 
 
 
 
 
 
 
 
 
 
 
 
Study Coordinator Signature 
Date 
Date of this phone contact 
/ 
/_  
 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the Final Visit for Initial Treatment Period scheduled on 
/ 
/  
 
at end of week 16. This visit will also be the Initiation of 2nd Treatment Period. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Final Visit for Initial Treatment Period; 
Initiation of 2nd Treatment Period 
(Visit 4-End of Week 16) 
Study Continuation: 
Yes 
No 
Is the subject continuing in the study (2nd Treatment Period)? 
 
 
If Yes, please proceed with Visit procedures. If No, please proceed with Early Termination Visit, and 
complete the Subject Disposition Form. 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Vital Signs: 
Height: 
  
   cm   / inches (circle one) 
Weight: 
  
 
kg   /  lbs 
(circle one) 
 
 
Urine Pregnancy Test Results: 
Positive 
Negative  N/A 
Name: 
Lot #: 
Exp. Date: 
 
 
 
 
Ear Exam: Observations and check for presence of cerumen (recommend cleaning procedure as 
needed). 
_ 
_ 
 
 
 
 
Physician Signature (for ear exam): 
_Date: 
_ 
 
 
Quality of Life Assessments: 
Yes 
No 
Scores 
Hit-6 Questionnaire (completed) 
 
Pittsburgh Sleep Quality Assessment (completed) 
 
BDI-II (completed) 
 
BAI (completed) 
 
BDI-II scores above 20 or BAI scores above 16 after treatment has commenced should be referred to 
the PI for consultation with Dr. Attix. If the subject answers in the affirmative to question 9 of the BDI- 
II form, he/she should be referred for mental health counseling on that same clinic visit. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
 
Device Treatment at the Clinical Site with new Treatment Card: 
Yes 
No 
Was a new Treatment Card (SD card) inserted into the device before treatment? 
 
 
Any side effects or AEs reported after device treatment? 
 
 
Was the device treatment aborted? 
 
 
Any complaints from subject? 
 
 
Any concerns about the subject? 
 
 
If Yes, to any questions above, please provide comment: 
 
 
 
 
 
 
I have reviewed the data from this visit and found the information to be complete and 
accurate.  I verify that all of the tasks have been performed. 
 
 
 
 
 
Principal Investigator Signature 
Date 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Administer Usability Questionnaire after completion of device training. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Collect and return old Treatment card (SD card) from the device to Scion NeuroStim (SNS). 

Study Coordinator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 18) 
 
A phone call to the subject is required every 2 weeks after Initiation of 2nd Treatment Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with daily device treatments? 
 
 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to any questions above, please provide comment: 
 
 
Date of this phone contact 
/ 
/_  
 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Study Coordinator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
 
SUBJECT ID:  
  
DATE:   
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 20) 
 
A phone call to the subject is required every 2 weeks after Initiation of 2nd Treatment Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with daily device treatments? 
 
 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to any questions above, please provide comment: 
 
 
Date of this phone contact 
/ 
/_  
 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Study Coordinator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 22) 
 
A phone call to the subject is required every 2 weeks after Initiation of 2nd Treatment Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with daily device treatments? 
 
 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to any questions above, please provide comment: 
 
 
Date of this phone contact 
/ 
/_  
 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Study Coordinator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 24) 
 
A phone call to the subject is required every 2 weeks after Initiation of 2nd Treatment Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with daily device treatments? 
 
 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to any questions above, please provide comment: 
 
 
Date of this phone contact 
/ 
/_  
 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 26) 
 
A phone call to the subject is required every 2 weeks after Initiation of 2nd Treatment Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with daily device treatments? 
 
 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to any questions above, please provide comment: 
 
 
 
 
 
 
 
 
 
 
 
Study Coordinator Signature 
Date 
Date of this phone contact 
/ 
/_  
 
• 
Review device compliance and proper operation of the device and delivery of treatments. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the Final Visit for 2nd Treatment Period (end of Week 28) and Start of 
Observation Period scheduled on 
/ 
/ 
. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
Final Visit for 2nd Treatment Period; 
Start of Observation Period 
(Visit 5-End of Week 28) 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Ear Exam: Observations and check for presence of cerumen (recommend cleaning procedure as 
needed). 
_ 
_ 
 
 
 
 
Physician Signature (for ear exam): 
_Date: 
_ 
 
Vital Signs: 
Height: 
  
   cm   / inches (circle one) 
Weight: 
  
 
kg   /  lbs 
(circle one) 
 
Quality of Life Assessments: 
Yes 
No 
Scores 
Hit-6 Questionnaire (completed) 
 
Pittsburgh Sleep Quality Assessment (completed) 
 
BDI-II (completed) 
 
BAI (completed) 
 
BDI-II scores above 20 or BAI scores above 16 after treatment has commenced should be referred to 
the PI for consultation with Dr. Attix. If the subject answers in the affirmative to question 9 of the BDI- 
II form, he/she should be referred for mental health counseling on that same clinic visit. 
 
 
 
 
I have reviewed the data from this visit and found the information to be complete and 
accurate.  I verify that all of the tasks have been performed. 
 
 
 
 
 
Principal Investigator Signature 
Date 
• 
Subject returns device to study coordinator. 
• 
Administer Usability Questionnaire. 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Collect and return Treatment card (SD card) from the device to Scion NeuroStim (SNS). 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 30) 
 
A phone call to the subject is required every 2 weeks after Start of Observation Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to the question above, please provide comment: 
 
 
 
 
 
 
 
 
 
 
 
Study Coordinator Signature 
Date 
Date of this phone contact 
/ 
/_  
 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 32) 
 
A phone call to the subject is required every 2 weeks after Start of Observation Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to the question above, please provide comment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Coordinator Signature 
Date 
Date of this phone contact 
/ 
/_  
 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 34) 
 
A phone call to the subject is required every 2 weeks after Start of Observation Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to the question above, please provide comment: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Coordinator Signature 
Date 
Date of this phone contact 
/ 
/_  
 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Study Coordinator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 36) 
 
A phone call to the subject is required every 2 weeks after Start of Observation Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to the question above, please provide comment: 
 
 
Date of this phone contact 
/ 
/_  
 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the next phone contact in 2 weeks, scheduled on 
/ 
/ 
. 

Study Coordinator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Phone Contact (Week 38) 
 
A phone call to the subject is required every 2 weeks after Start of Observation Period 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Subject Compliance: 
Yes 
No 
Is the subject compliant with Daily Headache Diary and uploads? 
 
 
If No, to the question above, please provide comment: 
 
 
Date of this phone contact 
/ 
/_  
 
• 
Review Daily Headache Diary completion and upload to gmail account each day. 
• 
Remind subject of the Final Study Visit (end of Week 40) scheduled on 
/ 
/ 
_. 

Principal Investigator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Final Study Visit 
(Visit 6-End of Week 40) 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Vital Signs: 
Height: 
  
   cm   / inches (circle one) 
Weight: 
  
 
kg   /  lbs 
(circle one) 
 
 
Ear Exam: Observations and check for presence of cerumen (recommend cleaning procedure as 
needed). 
_ 
_ 
 
 
 
 
Physician Signature (for ear exam): 
_Date: 
_ 
 
Quality of Life Assessments: 
Yes 
No 
Scores 
Hit-6 Questionnaire (completed) 
 
Pittsburgh Sleep Quality Assessment (completed) 
 
BDI-II (completed) 
 
BAI (completed) 
 
BDI-II scores above 20 or BAI scores above 16 after treatment has commenced should be referred to 
the PI for consultation with Dr. Attix. If the subject answers in the affirmative to question 9 of the BDI- 
II form, he/she should be referred for mental health counseling on that same clinic visit. 
 
 
 
 
 
 
I have reviewed the data from this visit and found the information to be complete and 
accurate.  I verify that all of the tasks have been performed. 
• 
Complete Subject Disposition Form (Subject Status=Completed) 

Principal Investigator Signature 
Date 
Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Subject Disposition Form 
 
Select the Subject's Status for the Study: □ Excluded (select reason below) 
□Screen Failure 
□Physician Decision 
□ Discontinued (select reason below) 
□Adverse Event 
□Protocol Violation 
□Withdrawal by Subject 
□Physician Decision 
□Lost to Follow-up 
□Lack of Efficacy 
□Study Terminated by Sponsor 
□Lack of Qualifying Event 
□ Completed 
Comments:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Coordinator Signature 
Date 

Version: 09Aug2016 
CONFIDENTIAL 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
  
DATE:   
 
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Early Termination Visit 
 
 
Adverse Events and Concomitant Medication Assessment: 
Yes 
No 
Any Adverse Events (AEs) since last visit? 
 
 
If Yes, please complete AE form. 
Any new medications or changes in medications since last visit? 
 
 
If Yes, please add medication(s) to the Concomitant Medication form. Acute abortive medications 
and migraine prophylactic medications should not be changed during the clinical trial. 
 
Vital Signs: 
Height: 
  
   cm   / inches (circle one) 
Weight: 
  
 
kg   /  lbs 
(circle one) 
 
 
Ear Exam: Observations and check for presence of cerumen (recommend cleaning procedure as 
needed). 
_ 
_ 
 
 
 
 
Physician Signature (for ear exam): 
_Date: 
_ 
 
Quality of Life Assessments: 
Yes 
No 
Scores 
Hit-6 Questionnaire (completed) 
 
Pittsburgh Sleep Quality Assessment (completed) 
 
BDI-II (completed) 
 
BAI (completed) 
 
BDI-II scores above 20 or BAI scores above 16 after treatment has commenced should be referred to 
the PI for consultation with Dr. Attix. If the subject answers in the affirmative to question 9 of the BDI- 
II form, he/she should be referred for mental health counseling on that same clinic visit. 
 
 
 
 
I have reviewed the data from this visit and found the information to be complete and 
accurate.  I verify that all of the tasks have been performed. 
 
 
 
 
 
Principal Investigator Signature 
Date 
• 
Complete Subject Disposition Form (Subject Status=Discontinued; select reason) 
• 
Return device and study related materials, as needed. 

Version 09Aug2016 
 
The following questionnaires are to be completed by the study patients in 
accordance with establishing the acceptance criteria set forth in the usability 
validation plan (*PLN-04-ENG-004-SN, section 11). Questionnaires will be 
completed at the end of the training period, once a treatment is completed, at 
the 2-week clinic visit, and at the end of the first and second treatment 
periods.  The following acceptance criteria will be addressed during the 
evaluation periods: 
 
• At the completion of training: 
o Device comfort, ease of use, intuitive nature of GUI, ability to hear 
alarm, identification of labeling, etc. 
• At the 2-week clinic visit: 
o Device comfort, ease of use, device cleaning, device storage, 
treatment protocol 
• End of the study periods 
o Device comfort, ease of use, treatment protocol 

Version 09Aug2016 
 
Usability Questionnaire after Completion of Training: 
 
Date:  
 
Subject ID 
_ 
1. Is the headset comfortable enough that you will be able to use it consistently 
during the study period? 
a. Yes 
b. Probably 
c. Not sure 
d. Probably not 
e. No 
2. Over all, does the device seem easy to use? 
a. Yes 
b. Not sure 
c. No 
3. Is the touchscreen easy to use? 
a. Yes 
b. No opinion 
c. No 
4. Are you able to hear the tones from the control unit? 
a. Always 
b. Not all the time 
c. Not sure 
d. Never 

Version 09Aug2016 
 
 
5. Is the labeling on the control unit and headset clear and 
understandable? 
a. Yes 
b. Not in all cases 
c. No opinion 
d. No 
6. Is the device easy to unpack and assemble? 
a. Yes 
b. I have some trouble with it 
c. No opinion 
d. No 
7. Are you comfortable with the entire treatment procedure, including use 
of the wedge pillow and lying down with your head facing up until the 
end of treatment chime sounds? 
a. Yes 
b. I have some trouble with it 
c. No opinion 
d. No 
8. Do you have any other observations or comments you would like to 
make at this time? 

Version 09Aug2016 
 
User experience questionnaire after first treatment session: 
 
“Remember we said in the Informed Consent that we are testing a brainstem 
neuromodulator.  Now that you have used the device for the first time, we want 
to ask you some questions.” 
1. What sounds, if any, did you hear? 
2. Did you feel any pressure from the earpieces in your ear canals? 
3. Did you detect a very slight sensation in your head or ears, such as a weak 
electrical current might have made? 
4. Did you notice any change in the clarity of your vision during the treatment? 
5. At any point, did you notice any changes in temperature in your ear canals? 
6. Did you experience any dizziness or nausea? 
7. Could you tell from the control unit screen when the stimulus period started 
and ended? 
8. Did you feel relaxed during the treatment? 
9. Any other comments you’d like to make? 

Subject ID: _________                                                          Site #: _______________ 
Date: ______________                                                         Protocol #: ____________ 
Version: 09AUG2016 
CONFIDENTIAL  
 
 
Answers to Subject Questions after first use of TNM Device: 
“Remember we said in the Informed Consent that we are testing a brainstem 
neuromodulator.  Now that you have used the device for the first time, we want to ask you 
some questions.” 
 
1. What sounds, if any, did you hear? 
 
 
 
________________________________________________________________________ 
 
2. Did you feel any pressure from the earpieces in your ear canals? 
 
 
________________________________________________________________________ 
 
________________________________________________________________________ 
 
 
3. Did you detect a very slight sensation in your head or ears, such as a weak 
electrical current might have made? 
 
________________________________________________________________________ 
 
________________________________________________________________________ 
 
4. Did you notice any change in the clarity of your vision during the treatment? 
 
________________________________________________________________________ 
 
________________________________________________________________________ 
 
5. At any point, did you notice any changes in temperature in your ear canals? 
 
________________________________________________________________________ 
 
_______________________________________________________________________ 
 
6. Did you experience any dizziness or nausea? 
 
________________________________________________________________________ 
 
________________________________________________________________________ 

Subject ID: _________                                                          Site #: _______________ 
Date: ______________                                                         Protocol #: ____________ 
Version: 09AUG2016 
CONFIDENTIAL  
 
 
 
7. Could you tell from the control unit screen when the stimulus period started and 
ended? 
 
________________________________________________________________________ 
 
________________________________________________________________________ 
 
8. Did you feel relaxed during the treatment? 
 
________________________________________________________________________ 
 
________________________________________________________________________ 
 
9. Any other comments you’d like to make? 
 

Version 09Aug2016 
 
Questionnaire for the 2-week Clinic visit: 
 
Date:  
 
Subject ID 
_ 
1. Do you find the headset to be comfortable enough to continue with your 
treatments? 
a. Yes 
b. Not sure 
c. No 
2. Do you find that the device is easy to use at home? 
a. Yes 
b. No opinion 
c. It is not easy, but I can keep doing it 
d. No 
3. Is the amount of time you spend treating per day: 
a. Enjoyable 
b. Acceptable 
c. No opinion 
d. Challenging to maintain 
e. Impossible to maintain 
4. Is the device easy to clean at home? 
a. Yes 
b. No 

Version 09Aug2016 
 
 
5. Storing the device between uses: 
a. I have no problem storing the Device safely 
b. It is challenging to store the Device safely 
c. I cannot store the Device safely 
6. Are you able to complete treatments without interruption? 
a. Yes 
b. Most of the time 
c. Not all of the time 
d. No 
7. Have you dropped the device or has it been damaged as far as you know? 
a. Yes (if yes, do you feel that you created a hazard for yourself or others?) 
b. No 
8. Do you have any other comments or observations at this time? 

Version 09Aug2016 
 
 
Questionnaire for the End of the first 3-month treatment period: 
 
Date:  
 
Subject ID 
_ 
1. Did you find the headset to be comfortable enough to continue with your 
treatments? 
a. Yes 
b. No 
2. Did you find that the device is easy to use at home? 
a. Yes 
b. No opinion 
c. It was not easy, but I kept doing it 
d. No 
3. Was the amount of time you spent treating per day: 
a. Enjoyable 
b. Acceptable 
c. No opinion 
d. Challenging to maintain 
e. Impossible to maintain 
4. Storing the device between uses: 
a. I had no problem storing the Device safely 
b. It was challenging to store the Device safely 
c. I could not store the Device safely 

Version 09Aug2016 
5. Were you able to complete treatments without interruption? 
a. Yes 
b. Most of the time 
c. Not all of the time 
d. No 
6. Have you dropped the device or has it been damaged as far as you know? 
a. Yes (if yes, do you feel that you created a hazard for yourself or others?) 
b. No 
7. How would you rate your overall experience with the device? 
a. Very positive 
b. Somewhat positive 
c. No opinion 
d. Somewhat negative 
e. Very negative 
f. What are some reasons for your opinion? 
8. Do you think that you were in the active treatment group or the placebo group? 
a. Active 
b. Placebo 
9. Please provide the reason(s) for your answer to question #8. 
10. Do you have any final comments to share? 

Version 09Aug2016 
 
 
Questionnaire for the End of the second 3-month treatment period: 
 
Date:  
 
Subject ID 
_ 
1. Did you find the headset to be comfortable enough to continue with your 
treatments? 
a. Yes 
b. No 
2. Did you find that the device is easy to use at home? 
a. Yes 
b. No opinion 
c. It was not easy, but I kept doing it 
d. No 
3. Was the amount of time you spent treating per day: 
a. Enjoyable 
b. Acceptable 
c. No opinion 
d. Challenging to maintain 
e. Impossible to maintain 
4. Storing the device between uses: 
a. I had no problem storing the Device safely 
b. It was challenging to store the Device safely 
c. I could not store the Device safely 

Version 09Aug2016 
5. Were you able to complete treatments without interruption? 
a. Yes 
b. Most of the time 
c. Not all of the time 
d. No 
6. Have you dropped the device or has it been damaged as far as you know? 
a. Yes (if yes, do you feel that you created a hazard for yourself or others?) 
b. No 
7. How would you rate your overall experience with the device? 
a. Very positive 
b. Somewhat positive 
c. No opinion 
d. Somewhat negative 
e. Very negative 
f. What are some reasons for your opinion? 
8. Do you think that you were in the active treatment group or the placebo group? 
a. Active 
b. Placebo 
9. Please provide the reason(s) for your answer to question #8. 
10. Do you have any final comments to share?

Version: 09Aug2016 
 
 Scion NeuroStim Daily Headache Diary – Baseline Period 
• This form is for which calendar date? 
 
(day, month, year) 
• 
Did you have a headache today? 
☐ Yes 
☐ No 
• Do you feel that your headache was a migraine headache? 
☐ Yes 
☐ No 
 
• Maximum Pain Level (0-10 scale) on this date:   
 
 
• Duration of any headache (0-24 hours):   
 
 
• Check the box next to any symptoms associated with your headache: 
□ Nausea and/or vomiting? 
□ Dizziness? 
□ Sensitivity to light? 
□ Sensitivity to sound? 
□ Sensitivity to smells? 
□ None of the above 
 
Regarding your headache pain, did it: 
□ Mostly occur on one side of your head? 
□ Have a pulsating quality? 
□ Prevent you from undertaking routine physical activity 
(e.g., walking, climbing stairs)? 
□ Become worse during physical activity? 
□ None of the above 
--------------------------------------------------------------------------------------------- 
• Check the box if you took any medications to treat your headache? (If you took medications, 
list types and dosages below): 
☐  Yes 
Please list types and dosages below: 
 
1) 
2) 
3) 
 
 
---------------------------------------------------------------------------------------------- 
Do you have any side effects to record in the space below?  ☐ Yes 
☐ No 
 
Please report to your study doctor, as soon as possible, any side effect that you consider to be 
serious or severe. 
 
Side Effect 1: 
 
Start Date 1: 
Stop Date 1: 
 
List any additional side effects below 

Version: 09Aug2016 
 
Scion NeuroStim Daily Headache Diary – Treatment Period 1 
 
• This form is for which calendar date? 
  
 (day, month, year) 
 
• Did you have a headache today? 
☐ Yes 
☐ No 
• Do you feel that your headache was a migraine headache? 
☐ Yes 
☐ No 
 
• Maximum Pain Level (0-10 scale) on this date:   
 
 
• Duration of any headache (0-24 hours):   
 
 
• Check the box next to any symptoms associated with your headache: 
□ Nausea and/or vomiting? 
□ Dizziness? 
□ Sensitivity to light? 
□ Sensitivity to sound? 
□ Sensitivity to smells? 
□ None of the above 
 
Regarding your headache pain, did it: 
□ Mostly occur on one side of your head? 
□ Have a pulsating quality? 
□ Prevent you from undertaking routine physical activity 
(e.g., walking, climbing stairs)? 
□ Become worse during physical activity? 
□ None of the above 
--------------------------------------------------------------------------------------------- 
• Check the box if you took any medications to treat your headache? (If you took medications, 
list types and dosages below): 
☐  Yes 
Please list types and dosages below: 
 
1) 
2) 
3) 
 
 
 
---------------------------------------------------------------------------------------------- 
Do you have any side effects to record in the space below?  ☐ Yes 
☐ No 
 
Please report to your study doctor, as soon as possible, any side effect that you consider to be 
serious or severe. 
 
Side Effect 1: 
 
Start Date 1: 
Stop Date 1: 
 
List any additional side effects below 

Version: 09Aug2016 
 
Scion NeuroStim Daily Headache Diary – Treatment Period 2 
 
• This form is for which calendar date? 
  
 (day, month, year) 
 
• Did you have a headache today? 
☐ Yes 
☐ No 
• Do you feel that your headache was a migraine headache? 
☐ Yes 
☐ No 
 
• Maximum Pain Level (0-10 scale) on this date:   
 
 
• Duration of any headache (0-24 hours):   
 
 
• Check the box next to any symptoms associated with your headache: 
□ Nausea and/or vomiting? 
□ Dizziness? 
□ Sensitivity to light? 
□ Sensitivity to sound? 
□ Sensitivity to smells? 
□ None of the above 
 
Regarding your headache pain, did it: 
□ Mostly occur on one side of your head? 
□ Have a pulsating quality? 
□ Prevent you from undertaking routine physical activity 
(e.g., walking, climbing stairs)? 
□ Become worse during physical activity? 
□ None of the above 
--------------------------------------------------------------------------------------------- 
• Check the box if you took any medications to treat your headache? (If you took medications, 
list types and dosages below): 
☐  Yes 
Please list types and dosages below: 
 
1) 
2) 
3) 
 
 
 
---------------------------------------------------------------------------------------------- 
Do you have any side effects to record in the space below?  ☐ Yes 
☐ No 
 
Please report to your study doctor, as soon as possible, any side effect that you consider to be 
serious or severe. 
 
Side Effect 1: 
 
Start Date 1: 
Stop Date 1: 
 
List any additional side effects below 

Version: 09Aug2016 
 
Scion NeuroStim Daily Headache Diary – Observation period 
 
• This form is for which calendar date? 
  
 (day, month, year) 
 
• Did you have a headache today? 
☐ Yes 
☐ No 
• Do you feel that your headache was a migraine headache? 
☐ Yes 
☐ No 
 
• Maximum Pain Level (0-10 scale) on this date:   
 
 
• Duration of any headache (0-24 hours):   
 
 
• Check the box next to any symptoms associated with your headache: 
□ 
Nausea and/or vomiting? 
□ 
Dizziness? 
□ 
Sensitivity to light? 
□ 
Sensitivity to sound? 
□ 
Sensitivity to smells? 
□ 
None of the above 
 
Regarding your headache pain, did it: 
□ 
Mostly occur on one side of your head? 
□ 
Have a pulsating quality? 
□ 
Prevent you from undertaking routine physical activity 
(e.g., walking, climbing stairs)? 
□ 
Become worse during physical activity? 
□ 
None of the above 
--------------------------------------------------------------------------------------------- 
• Check the box if you took any medications to treat your headache? (If you took medications, 
list types and dosages below): 
☐  Yes 
Please list types and dosages below: 
 
1) 
2) 
3) 
 
 
 
---------------------------------------------------------------------------------------------- 
Do you have any side effects to record in the space below?  ☐ Yes 
☐ No 
 
Please report to your study doctor, as soon as possible, any side effect that you consider to be 
serious or severe. 
 
Side Effect 1: 
 
Start Date 1: 
Stop Date 1: 
 
List any additional side effects below 

Version: 09Aug2016 
Confidential 
Page 
of  
 
 
Protocol: A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache 
Adverse Events/Adverse Device Effects 
SUBJECT ID:  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
□ Please check the box, if the subject did not experience any AEs/Adverse Device Effects (ADEs) during the study. 
(Initial/Date) 
 
Adverse 
Event 
Date of 
Onset 
dd/mmm/yyyy 
Outcome 
1=Resolved 
2=Resolved 
w/Sequelae 
3=Ongoing 
4=Unknown 
Date of 
Resolution 
dd/mmm/yyyy 
(If <24 hrs, 
please indicate 
Hrs/Mins) 
Intensity 
 
1=Mild 
2=Moderate 
3=Severe 
Action taken 
w/Study 
Device Tx 
1=None 
2=Reduced 
3=Interrupted 
4=Discontinued 
Relationship to 
Study Device 
1=Not Related 
2=Unlikely Related 
3=Possibly Related 
4=Probably Related 
5=Related 
Serious 
AE? 
 
1=No 
2=Yes 
(If Yes, 
Complete 
SAE/UADE 
Form) 
Unanticipated 
AE? 
1=No 
2=Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PI Signature (at end of clinical trial):   
 
Date:   
 

Version: 09Aug2016 
Confidential 
Page 
of  
 
 
Protocol: A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache 
Adverse Events/Adverse Device Effects 
SUBJECT ID:  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
□ Please check the box, if the subject did not experience any AEs/Adverse Device Effects (ADEs) during the study. 
(Initial/Date) 
 
Adverse 
Event 
Date of 
Onset 
dd/mmm/yyyy 
Outcome 
1=Resolved 
2=Resolved 
w/Sequelae 
3=Ongoing 
4=Unknown 
Date of 
Resolution 
dd/mmm/yyyy 
(If <24 hrs, 
please indicate 
Hrs/Mins) 
Intensity 
 
1=Mild 
2=Moderate 
3=Severe 
Action taken 
w/Study 
Device Tx 
1=None 
2=Reduced 
3=Interrupted 
4=Discontinued 
Relationship to 
Study Device 
1=Not Related 
2=Unlikely Related 
3=Possibly Related 
4=Probably Related 
5=Related 
Serious 
AE? 
 
1=No 
2=Yes 
(If Yes, 
Complete 
SAE/UADE 
Form) 
Unanticipated 
AE? 
1=No 
2=Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PI Signature (at end of clinical trial):   
 
 
Date:   
 

Version: 09Aug2016 
Confidential 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
 
PROTOCOL NUMBER:  
  
 
Serious Adverse Event (SAE)/ Unanticipated Adverse Device Effect (UADE) 
 
Adverse Event (AE) Term: 
Event Start Date 
 
/ 
/  
 
(dd/mmm/yyyy) 
Event End Date 
 
/ 
/  
 
(dd/mmm/yyyy) 
Is the event still ongoing? 
□Yes 
□No 
Type of Report: □Initial □Follow up □Final 
 
Demographics with no personal identifiers: 
 
 
 
 
 
Yes 
No 
Was the AE unanticipated (unexpected)? 
Was the AE caused by, or associated with the investigational device? 
Did the event improve or disappear after stopping device treatment? 
Is there a relationship of the event to any other suspect cause? 
Date of Birth: 
/ 
□Female 
Serious Criteria: (check all that apply) 
□Inpatient hospitalization or prolongation of hospitalization 
Date of Hospitalization 
 
/  
/   
 
of Discharge 
/ 
 /  
  
□Immediately Life Threatening (immediate risk of death) 
□Persistent or significant disability/incapacity 
□Congenital anomaly/Birth defect 
□Other important medical event which required an 
intervention to prevent permanent impairment 
□Death 
Date of Death 
/  
 

Version: 09Aug2016 
Confidential 
 
Scion NeuroStim, LLC 
 
 
SUBJECT ID:  
 
DATE:   
  
 
SITE #:  
  
PROTOCOL NUMBER:  
  
 
Serious Adverse Event (SAE)/ Unanticipated Adverse Device Effect (UADE) 
 
 
Briefly describe the presentation and clinical course, including medical treatment, of the 
event: (attach additional pages, if needed) 
 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
  
_ 
 
 
 
 
Please Note: For device clinical trials, investigators are required to submit a report of SAE/UADE 
to the sponsor and reviewing IRB as soon as possible, but no later than 10 working days after 
the investigator first learns of the event (21 CRF 812.150(a)(1)). However, if the SAE/UADE 
involves a death it must be reported within 24 hours of discovery. Any follow-up information 
will be submitted to the sponsor and IRB as soon as the relevant information is available. 
 
 
Signature/Date of person completing form:  
 
 
 
Signature/Date of Principal Investigator:  
 

Connecting your new Scion Trials email account to a 
smartphone or tablet 
 
This guide is in two sections. The first section covers Apple iPhones and iPads, and the second 
section covers Android smartphones and tablets. 
 
 
Section 1: Apple iPhones and iPads 
Adding security to your iPhone or iPad 
 
We ask that you set a passcode on the iPhone or iPad that you plan to use which, once set, will 
need to be entered when you turn on the iPhone or iPad. It is possible that you already have a 
passcode set. If you do not, follow these steps to add one: 
 
1. Go to the main screen of the iPhone or iPad that shows all of your icons and tap on the 
Settings icon. 
 
2. Go down to Touch ID & Passcode and tap on it, or it might just say Passcode depending on 
the model of iPhone or iPad that you have. 
 
 

3. Tap turn passcode on. 
 
 
 
4. Enter a passcode and re-enter it to confirm when prompted to do so. Remember what you 
set as the passcode, because you will need to enter it each time you want to use your device. 
 
Connecting your iPhone or iPad to your new Scion Trials email account 
 
1. Go to the App Store and search for the Gmail app. If you locate it correctly, the title of the 
app show as “Gmail – email from Google” as shown below. Tap GET to download it and enter 
the password for your Apple ID if prompted to complete the download. If you see the word 
OPEN next to the app listing then you already have the Gmail app on your device. 
 
 

2. Open the app and enter your new Scion Trials email address when prompted. The app should 
bring you to the inbox for the email account. 
 
3a. To write a new email on the iPhone version of the app, tap on the red box icon that has a 
pencil inside it at the top right corner of the inbox. 
 
 
 
3b. To write a new email on the iPad version of the app, tap on the red box icon that has a 
pencil inside it above the inbox. 
 
 

4. When you have finished writing the email, tap on the blue arrow at the top right corner to 
send the message: 
 
 

Section 2: Android smartphones and tablets 
Since there are so many different types of Android smartphones and tablets, this guide will 
describe the general steps involved. It is possible that this guide may exactly reflect the screens 
you see, but if not you should see general similarities on your screens. 
 
Adding security to your Android smartphone or tablet 
 
We ask that you set a passcode on the Android smartphone or tablet that you plan to use 
which, once set, will need to be entered when you turn on the smartphone or tablet in the 
future. It is possible that you already have a passcode set. If you do not, follow these steps to 
add one: 
 
1. Go to the settings on your Android smartphone or tablet and tap on Security. Then tap on 
Screen lock. 
 
 

2. Tap on PIN to make a numeric code. 
 
 
 
3. Enter the PIN code that you want to use and re-enter it if prompted to do so. Remember 
what you set as your PIN because you will need it in the future when you turn on your device. 
 
Connecting your Android smartphone or tablet to your new Scion Trials email account 
 
1. Go to the settings on your Android smartphone or table and tap on the Add Account setting. 
 
 

2. In the next screen tap on Google. 
 
 
 
3. In the next Add a Google Account screen if you are asked whether you want to create a new 
account or use an existing account, tap Existing. Then type your Scion Trials email address and 
password when prompted to do so. 
 
4. If you then see a screen asking you what you want to sync for this email account, only put a 
check mark next to Gmail. Clear the other check marks. 
 
 
 
 
That’s it! If you have any questions, please contact us at administration@sciontrials.com. 

Version: 09Aug2016 
CONFIDENTIAL 
 
 
Sponsor:  Scion NeuroStim, LLC (SNS) 
Protocol:  A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache 
Schedule of Visits and Procedures 
 
Procedures 
 
 
Screening 
Visit 
Baseline 
Period  (28 
days; 
weeks 1-4) 
Treatment 
Day 1 
Week 5 
Clinic Visit 
Day (week 
7; check on 
treatment 
experience) 
 
 
Phone 
Contact 
Week 9 
Phone 
Contact 
Week 11 
 
 
Phone 
Contact 
Week 13 
Phone 
Contact 
Week 15 
Informed Consent 
X 
 
 
Inclusion/Exclusion criteria 
X 
 
 
Headache History Questionnaire 
X 
 
 
Medical History 
X 
 
 
Medication Usage (Concomitant Medication) 
X 
X 
X 
X 
X 
X 
X 
Ear Exam (presence of cerumen) 
X 
X 
X 
 
 
Vital Signs (height & weight) 
X 
X 
X 
 
 
Device Treatment Training 
 
X 
X 
 
 
Device Treatment at Research Site 
 
X 
X 
 
 
Usability Questionnaire 
 
X 
X 
 
 
Train/Review Daily Headache Diary 
X 
X 
X 
X 
X 
X 
X 
X 
Quality of Life Questionnaires (HIT-6, 
Pittsburg Sleep, BDI-II, BAI) 
 
X 
 
 
Urine Pregnancy Test 
 
X 
 
 
Randomization 
 
X 
 
 
Dispense CVS Device 
 
X 
 
 
Collect Treatment Data from CVS-M Device 
 
 
 
Return CVS Device 
 
 
 
Adverse Event Reporting 
X 
X 
X 
X 
X 
X 
X 
X 

Version: 09Aug2016 
CONFIDENTIAL 
 
 
Sponsor:  Scion NeuroStim, LLC (SNS) 
Protocol:  A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache 
Schedule of Visits and Procedures 
 
Procedures 
Final Visit for Initial 
Tx Period (end of 
week 16); Also 
Initiation of 2nd Tx 
period 
Phone 
Contact 
Week 18 
 
 
Phone 
Contact 
Week 20 
Phone 
Contact 
Week 22 
Phone 
Contact 
Week 24 
Phone 
Contact 
Week 26 
Final Visit for 2nd 
Tx Period; end of 
Tx (end of week 
28); Start of 
Observation 
Period 
Informed Consent 
 
Inclusion/Exclusion Criteria 
 
Headache History Questionnaire 
 
Medical History 
 
Medication Usage (Concomitant Medicaton) 
X 
X 
X 
X 
X 
X 
X 
Ear Exam (presence of cerumen) 
X 
 
X 
Vital Signs (height & weight) 
X 
 
X 
Device Treatment Training 
 
Device Treatment at Research Site 
X 
 
Usability Questionnaire 
X 
 
X 
Train/Review Daily Headache Diary 
X 
X 
X 
X 
X 
X 
X 
Quality of Life Questionnaires 
X 
 
X 
Urine Pregnancy Test 
X 
 
Randomization 
 
Dispense CVS-M Device 
New treatment 
cards for all 
subjects 
 
Collect Treatment Data from CVS-M Device 
X 
 
X 
Return CVS Device 
 
X 
Adverse Event Reporting 
X 
X 
X 
X 
X 
X 
X 

Version: 09Aug2016 
CONFIDENTIAL 
 
 
Sponsor:  Scion NeuroStim, LLC (SNS) 
Protocol:  A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache 
Schedule of Visits and Procedures 
 
Procedures 
 
 
Phone 
Contact 
Week 30 
 
 
Phone 
Contact 
Week 32 
Phone 
Contact 
Week 34 
 
 
Phone 
Contact 
Week 36 
Phone 
Contact 
Week 38 
Final Study visit 
(end of week 40) 
Or Early 
Termination Visit 
Informed Consent 
 
 
 
Inclusion/Exclusion Criteria 
 
 
 
Headache History Questionnaire 
 
 
 
Medical History 
 
 
 
Medication Usage(Concomitant Medicatio n 
X 
X 
X 
X 
X 
X 
Ear Exam (presence of cerumen) 
 
 
 
X 
Vital Signs (height & weight) 
 
 
 
X 
Device Treatment Training 
 
 
 
Device Treatment at Research Site 
 
 
 
Usability Questionnaire 
 
 
 
Train/Review Daily Headache Diary 
X 
X 
X 
X 
X 
Quality of Life Questionnaires 
 
 
 
X 
Urine Pregnancy Test 
 
 
 
Randomization 
 
 
 
Dispense CVS-M Device 
 
 
 
Collect Treatment Data from CVS-M Device  
 
 
Return CVS Device 
 
 
 
Adverse Event Reporting 
X 
X 
X 
X 
X 
X