A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment With the Cryo-Touch III Device for Upper Limb Spasticity
Phase: NA
Conditions: Upper Limb Spasticity
Sponsor: Pacira Pharmaceuticals, Inc

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
 
A PROSPECTIVE, NON-RANDOMIZED, UNBLINDED STUDY 
EVALUATING THE TREATMENT WITH THE CRYO-TOUCH III 
DEVICE FOR UPPER LIMB SPASTICITY 
 
 
Protocol Number: 
MYO-0709 
Protocol Date: 
November 30, 2012 
Sponsor & Address: 
myoscience, Inc. 
1600 Seaport Blvd. Suite 450 
Redwood City, CA 94063 
Sponsor Representative(s): 
John Allison 
Vice President, Research and Development 
myoscience, Inc.  
650-474-2600 (office) 
650-474-2900 (fax) 
 
Tracey Henry 
Vice President, RA/QA, Operations 
myoscience, Inc. 
650-474-2600 (office) 
650-474-2900 (fax) 
 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
Protocol Synopsis 
 
Title 
A Prospective, Non-Randomized, Unblinded Study Evaluating the 
Treatment with the Cryo-Touch III Device for Upper Limb Spasticity 
Study Device 
Cryo-Touch III (a.k.a. PCP 1.0) 
Study Objective 
The Cryo-Touch III study is a post-market, off-label, prospective, 
multicenter study of the Cryo-Touch III Device for treatment of Upper Limb 
Spasticity. 
 
The objective of the Study is to evaluate the temporary relief of pain and 
symptoms in the upper arm in subjects with Upper Limb Spasticity 
secondary to Stroke, Cerebral Palsy, Multiple Sclerosis, traumatic brain 
injury or similar disorder. 
Treatment Groups 
Single  
Duration of Study 
Enrollment and follow-up is expected to take approximately 4 months.  A 
subject will participate for approximately 10 weeks. 
Study Population 
Male or female subjects, ages 18 and older, diagnosed with pain due to 
severe spasticity of the upper limb(s).  
Total Number of 
Subjects 
Up to 20.  A minimum of 10 and a maximum of 20 subjects.  
Number of Sites 
1-2 
Inclusion Criteria 
Eligible subjects must meet the following criteria:  
 
1. Male or female, 18 years of age and older. 
2. Trial participants must have a confirmed diagnosis that results in 
spasticity involving muscle innervated by the musculocutaneous 
nerve (MCN).  
3. Any medications must be maintained on a stable schedule for at 
least two weeks prior to treatment.  No washout period is allowed. 
4. Must have an average score on the Modified Ashworth Scale for 
Spasticity of ≥ 2 over the last 30 days in the elbow. 
5. Subject, in the Investigator’s opinion, will not be exposed to 
unacceptable risk by participation. 
Exclusion Criteria 
A subject is ineligible if one or more of the following criteria applies:  
 
1. Previous surgical intervention that altered the target neural anatomy 
of the upper limb. 
2. Any injection (neurolytic, sclerosing, anesthetic, etc.) to the upper 
limb within the last 4 months. 
3. Current enrollment in an investigational drug or device study that 
specifically targets spasticity management.  
4. Allergy or intolerance to local anesthesia. 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
5. Any local skin condition at the treatment site that in the 
investigator’s opinion would adversely affect treatment or 
outcomes. 
6. Any chronic medication use (prescription, over-the-counter, etc.) 
that in the investigator’s opinion would affect study participation or 
subject safety.  
7. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, 
cold urticaria, Raynaud’s disease, open and/or infected wounds. 
8. Diagnosis of progressive neurologic diseases such as ALS.  
9. For any reason, in the opinion of the investigator, the subject may 
not be a suitable candidate for study participation (i.e., history of 
noncompliance, drug dependency, any related upper limb injury, 
etc.). 
 
Study Visit Schedule 
1. 
Visit 1/Screening (-30 Days to Day 0) 
2. 
Visit 2/Treatment (Day 0)  
3. 
Visit 3/ Maintenance (Day 7) 
4. 
Visit 4/ Maintenance (Day 30)  
5. 
Visit 5/Study Exit (Day 56) – Telephone Follow-Up 
Primary Outcome 
A decrease in pain and symptoms caused by hypertonia of the upper arm as 
measured by an improvement of 1 point or greater on the Modified 
Ashworth Scale at Day 7. 
Secondary Outcomes 
1. Improvement in spasticity as measured by the Tardieu Scale. 
2. Improvement in spasm frequency and intensity as measured by the 
Penn Spasm Score. 
3. Improvement in upper extremity motor recovery as measured by the 
Fugl-Meyer Scale (post stroke subjects only). 
4. Subject assessed change in Mean Spasticity Numerical Rating Scale 
(NRS) Score. 
5. Improvement in pain as assessed by visual analog scale (VAS). 
6. Duration of treatment effect. 
 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
Table of Contents 
 
Protocol Synopsis ................................................................................................................. 2 
Declaration of Investigator ................................................................................................... 6 
1. Introduction ..................................................................................................................... 7 
1.1. 
Background ........................................................................................................................ 7 
1.2. 
Device Description .............................................................................................................. 7 
1.3. 
Regulatory Status ............................................................................................................... 8 
2. 
Study Protocol............................................................................................................... 9 
2.1. 
Design ................................................................................................................................ 9 
2.2. 
Study Duration ................................................................................................................... 9 
2.3. 
Sample Size ........................................................................................................................ 9 
2.4. 
Subject Inclusionary Criteria ............................................................................................. 9 
2.5. 
Subject Exclusionary Criteria ............................................................................................ 9 
2.6. 
Schedule of Events............................................................................................................ 10 
2.6.1. 
Visit 1/Screening (Day -30 to Day 0) .......................................................................................... 10 
2.6.2. 
Visit 2/Treatment (Day 0) .......................................................................................................... 10 
2.6.2.1. 
Pre-Treatment/Evaluation Preparation ..................................................................................... 10 
2.6.2.2. 
Treatment ................................................................................................................................... 12 
2.6.2.3. 
Post-Treatment ........................................................................................................................... 12 
2.6.3. 
Visit 3/ Maintenance (Day 7) & Visit 4/Maintenance (Day 30) ..................................................... 12 
2.6.4. 
Visit 5/Study Exit (Day 56) – Telephone Follow-Up ................................................................... 12 
3. 
Outcome Measures and Assessments ........................................................................... 13 
3.1.1. 
Primary Outcome Measure ........................................................................................................ 13 
3.1.2. 
Secondary Outcome Measures ................................................................................................... 13 
3.1.3. 
Ancillary Measures (Potential measures not part of analysis)........................................................ 14 
Subject Post-Treatment Questionnaire (See Appendix) ............................................................................... 14 
3.1.4. 
Anticipated Observations (AO) [Data Collection Tool] ................................................................ 14 
3.1.5. 
Safety Measures [Data Collection] ............................................................................................. 15 
3.2. 
Adverse Event Reporting ................................................................................................. 15 
3.3. 
Statistical Analysis Plan ................................................................................................... 16 
4. 
Risk/Benefit Analysis .................................................................................................. 16 
4.1. 
Benefits ............................................................................................................................ 16 
4.2. 
Risks ................................................................................................................................ 16 
5. 
Study Management and Quality Control ...................................................................... 16 
5.1. 
Data Collection ................................................................................................................. 16 
5.2. 
Investigator Responsibilities ............................................................................................. 16 
5.2.1. 
Compliance with Good Clinical Research Practice ...................................................................... 16 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
5.2.2. 
Institutional Review Board (IRB) ............................................................................................... 17 
5.2.3. 
Device Accountability ............................................................................................................... 17 
5.2.4. 
Confidentiality.......................................................................................................................... 18 
5.2.5. 
Record Retention ...................................................................................................................... 18 
5.3. 
Sponsor Responsibilities ................................................................................................... 18 
5.3.1. 
Study Monitoring...................................................................................................................... 19 
5.3.2. 
Protocol Revisions .................................................................................................................... 19 
6. 
Data Ownership .......................................................................................................... 19 
Appendix A: Abbreviations ................................................................................................. 20 
Appendix B: Schedule of Events ......................................................................................... 21 
Appendix C:  Validated Assessment Tools ........................................................................... 22 
Appendix D: Subject Post-Treatment Questionnaire ............................................................ 45 
 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
Declaration of Investigator 
 
I confirm that I understand the protocol and agree to conduct the study as detailed herein. 
I will not make changes in the protocol without approval from the Sponsor, except when 
necessary to protect the safety, rights, or welfare of subjects. 
 
I agree to personally conduct or supervise the described investigation. I agree to ensure 
that all associates, colleagues, and employees assisting in the conduct of the study are informed 
about their obligations in meeting the above commitments. 
 
I agree to inform any subjects, or any persons in the study, that the device has been 
approved for market by the US FDA, currently is contraindicated in the study population and has 
not previously been studied in this population, and I will ensure that the requirements relating to 
obtaining informed consent in 21 CFR Part 50 and Institutional Review Board (IRB) review and 
approval in 21 CFR Part 56 are met. 
 
I agree to report to the Sponsor adverse experiences that occur in the course of the 
investigation(s) in accordance with 21 CFR 812.150(a)(1). I have read and understand the 
information in the product description, including any potential risks and side effects of the 
product. 
 
I agree to maintain adequate and accurate records in accordance with 21 CFR 812.140 
and to make those records available for inspection in accordance with 21 CFR 812.140. 
 
I will ensure the IRB complies with the requirements of 21 CFR Part 56 and will be 
responsible for the initial and continuing review and approval of the clinical investigation. I also 
agree to promptly report to the IRB and Sponsor all changes in the research activity and all 
unanticipated problems involving risks to human subjects or others. Additionally, I will not make 
any changes in the research without Sponsor and IRB approval, except where necessary to 
eliminate apparent immediate hazards to human subjects. 
 
I agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements in 21 CFR Part 812.110 and 812.150. I also 
agree to adhere to the internationally recognized Declaration of Helsinki, International 
Conference on Harmonisation (ICH) guidelines, and Good Clinical Practices (GCP). 
 
Signature: ________________________________________ Date: ____________________ 
 
Printed Name: _____________________________________ 
 
 
 
 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
1. Introduction 
1.1. Background 
Spasticity, common in neurological disorders, is part of the upper motor neuron 
syndrome displaying increased tone, clonus, spasms, spastic dystonia and co-
contractions.  The impact of spasticity on the patient varies from a subtle 
neurological sign to severe spasticity causing pain and contractures. Upper limb 
spasticity (ULS) is the rapid contraction or shortening of the muscles in the arm 
causing abnormal muscle movements in the elbow, wrist and fingers. It has been 
reported that over 1 million Americans with traumatic injury to the brain or spinal 
cord, stroke, multiple sclerosis and cerebral palsy experience ULS.  Tightly 
clenched fists, twisted wrist and elbow joints, and fixed arms in flexed positions 
result in extreme discomfort, pain and spasm.  A nonsurgical, minimally invasive, 
effective approach to pain associated with ULS is desirable. 
Myoscience, Inc. (Redwood City, CA) has developed a pain management device 
– the Cryo-Touch III – for a novel, minimally invasive procedure using focused 
cold therapy to target sensory nerve tissue and offer long-lasting pain relief 
through cryoanalgesia.  The device operates on the well-established cryobiology 
principle that localized exposure to controlled, moderately low temperature 
conditions can alter tissue function.  The therapy treats nerves via a probe in the 
form of an assembly of small diameter needles, creating a highly localized, low 
temperature treatment zone around the probe.  This focused cold therapy creates a 
conduction block that prevents nerve signaling.  Prior studies of the Cryo-Touch, 
Cryo-Touch II, Cryo-Touch III (a.k.a. PCP 1.0) devices have provided 
preliminary evidence of effectiveness on motor nerves and have been shown to be 
safe with no serious device-related adverse events.  
1.2. Device Description 
The Cryo-Touch III Device (a.k.a. PCP 1.0) (Figure 1) is a minimally invasive 
needle-based device. The device consists of a re-usable portable Control Unit, 
Handpiece, single use Cryoprobes (Figure 2) and Cryogen Cartridges. The 
Control Unit and Handpiece are powered by the Control Unit utilizing connection 
to a standard power outlet.  The system is microprocessor controlled. Its 
functionality is driven by an operator controlled on/off switch. The unit displays 
indicator lights to guide the operator.  
The system produces the desired effects through initiation of a cooling cycle. 
Each cooling cycle is initiated by subcutaneous insertion of the Cryoprobe into 
the selected site and activation of the cryogen flow. A freezing zone forms around 
the tip of the Cryoprobe and the adjacent tissue. The Cryogen Cartridges are 
provided in individually sealed pouches. Each cartridge contains a nitrous oxide 
cylinder encased with a safety cap and filter.  

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
The Cryoprobes are supplied in sterile packaging and are single-patient use. The 
Cyroprobe tips are closed, therefore no cryogen enters the insertion site. A skin 
warmer provides warming at the base of the Cryoprobe tips to keep the skin 
surface above freezing temperatures.  
 
 
 
 
Figure 1.  Picture of Cryo-Touch III Device.  
 
 
 
 
 
Figure 2. Picture of the Cryoprobe. 
 
1.3. Regulatory Status 
The myoscience Cryo-Touch III Device has been cleared by the US FDA as a 
class II medical device, K120415. Approved indications include general tissue 
A. Control Unit 
B. Handpiece 
C. Cryoprobe 
D. Cryogen Cartridge 
C
B
D
A. Skin Warmer 
B. Cryoprobe Tips 
B
A
A

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
destruction during surgical procedures and cryo-treatment of peripheral nerves to 
block pain.  
2. Study Protocol 
2.1. Design 
This is an 8 week, post-market, prospective, non-randomized, unblinded multi-
center study of the Cryo-Touch III Device for treatment of Upper Limb 
Spasticity.   
 
The study device is being studied per its current labeling in a currently 
contraindicated population. 
2.2. Study Duration  
Study enrollment and follow-up is expected to take approximately 4 months. 
2.3. Sample Size 
Up to 20 subjects will be enrolled in the study.  A minimum of 10 subjects and a 
maximum of 20 subjects will be included. 
 
Male and female subjects will be included without discrimination by gender, and 
subjects of all races and ethnicities will be equally eligible to participate in the 
study. 
2.4. Subject Inclusionary Criteria 
1. Male or female, 18 years of age and older. 
2. Confirmed diagnosis that results in spasticity involving muscle innervated by 
the musculocutaneous nerve (MCN).  
3. Stable use of medications (if applicable) for > two weeks prior to treatment.  
No washout period is allowed. 
4. Average score on the Modified Ashworth Scale for Spasticity of ≥ 2 over the 
last 30 days in the elbow. 
5. Subject, in Investigator’s opinion, will not be exposed to unacceptable risk by 
participation. 
2.5. Subject Exclusionary Criteria 
1. Previous surgical invention that altered the target neural anatomy of the upper 
limb. 
2. Any injection (neurolytic, sclerosing, anesthetic, etc.) to the upper limb within 
the last 4 months. 
3. Current enrollment in an investigational drug or a device study that 
specifically targets spasticity management.  

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
4. Allergy or intolerance to local anesthesia. 
5. Any local skin condition at the treatment site that in the investigator’s opinion 
would adversely affect treatment or outcomes. 
6. Any chronic medication use (prescription, over-the-counter, etc.) that in the 
investigator’s opinion would affect study participation or subject safety.  
7. Diagnoses of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold 
urticaria, Raynaud’s Disease, open and/or infected wounds. 
8. Diagnoses of progressive neurologic diseases such as ALS.  
9. For any reason, in the opinion of the investigator, the subject may not be a 
suitable candidate for study participation (i.e., history of noncompliance, drug 
dependency, any related upper limb injury, etc.). 
2.6. Schedule of Events 
See Appendix B. 
 
2.6.1. 
Visit 1/Screening (Day -30 to Day 0) 
Potential subjects will undergo screening against the study’s eligibility 
criteria.  Subjects will be informed of all study activities and requirements. 
After the subject has met all criteria and had ample opportunity to ask and 
have questions answered, an informed consent form will be signed and a 
copy provided to the subject. 
 
The investigator, or designee, will document the subject’s medical history, 
demographic information, concomitant medications/concurrent procedures, 
and any other required data points.  
 
The subject will be scheduled for the next visit.  The Visit 1/ Screening and 
Visit 2/ Treatment may occur on the same day. Every effort will be made to 
reduce the time between Screening and Treatment Visits if possible. 
 
2.6.2. 
Visit 2/Treatment (Day 0)  
2.6.2.1. Pre-Treatment/Evaluation Preparation 
 
No special preparation by the subject is required prior to the treatment.  
The investigator will reaffirm eligibility criteria and the subject’s 
willingness to continue participation in the trial.  Any changes in 
concomitant medications/concurrent procedures will be recorded.  Any 
adverse events that may have occurred prior to treatment will be 
documented as a change in medical history.  
 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
The target nerves will be located using adjacent anatomic landmarks.  
Non-invasive ultrasound imaging of the treatment area may be captured.  
Nerve stimulation may be used to assess location of nerves via a 
percutaneous nerve stimulator or a transcutaneous nerve stimulator.  
The Cryo-Touch III Device will be used per the Instructions for Use on 
awake subjects who are prepared with dermal anesthesia only.  The skin in 
the treatment area will be cleansed with alcohol.  Local anesthetic will be 
injected into target sites with the goal of complete cutaneous anesthesia at 
the target treatment areas prior to the treatment.   
The target of treatment are the musculocutaneous nerves (peripheral 
nerves).  The nerves will be treated in a linear fashion to block the nerve at 
a location deemed appropriate by the investigator (see Figure 3).  
   
 
Figure 3: Nerve map of intended treatment. 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
2.6.2.2. Treatment 
The Cryo-Touch III Device will have been prepared by the trained 
investigator (or Sponsor designee) according to the Instructions for Use 
(IFU) as provided by myoscience (see supplementary material). 
Representatives of myoscience may be present at the treatment. 
Photography and videography may be captured during the treatment.  
Varying treatment algorithms will be pre-determined by the sponsor and 
placed into cohorts as appropriate for analysis.  This is intended to 
determine the most effective method of treatment and to optimize the 
algorithm.  Algorithms may include the following parameters: length of 
treatment, number of treatment cycles, probe tip design, and probe length. 
If at any time the device does not perform as expected, the investigator (or 
designee) will follow procedures as outlined in the IFU.  
2.6.2.3. Post-Treatment 
Upon completion of treatment, the treatment area will be cleansed and the 
skin will be left undressed.  Pressure to the treatment area with gauze for 
5-10 minutes may be applied to minimize bleeding.  The subject will be 
instructed in post-treatment care.   
The subject will be instructed to report any adverse events or treatment 
side effects (e.g., excessive redness, swelling, bruising, soreness, altered 
sensation, etc.) to the investigator between and at follow-up visits.  Non-
invasive ultrasound may be used to assess the volume and location of the 
soft tissue treated below the dermis.  Photography and/or videography 
may be obtained.  
The subject will be scheduled and instructed regarding their follow-up 
visits and discharged from the clinic. 
2.6.3. 
Visit 3/ Maintenance (Day 7) & Visit 4/Maintenance (Day 30)  
Subject will be evaluated and data collected per the schedule of events.  
(Appendix B). Any changes in concomitant medications/concurrent 
procedures will be assessed.  Any anticipated observations, adverse events, 
and/or SAE/UADE of the previous treatment site(s) will be documented and 
accessed.  Non-invasive ultrasound imaging of the treatment area may be 
captured.  Photography may be taken of the treatment area.  
2.6.4. 
Visit 5/Study Exit (Day 56) – Telephone Follow-Up 
Subject will be contacted via telephone and data collected since the last visit 
per the schedule of events.  Any changes in concomitant 
medications/concurrent procedures will be assessed.  Any anticipated 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
observations, adverse events, and/or SAE/UADE of the previous treatment 
site(s) will be documented.  
If the treatment effect remains at Day 56, the subject will be followed every 
four (4) weeks via telephone until there is no longer any effect noted, up to a 
total of 112 days post-treatment.  Any clinically significant adverse event will 
be followed until resolution. The subject will exit the study once there are no 
longer treatment effects and no ongoing clinically significant events.  
Study exit data will be collected and the subject reminded to contact the 
investigator if any new, previously unreported event occurs related to the 
treatment. 
A subject is considered to have exited the study after completing all 
scheduled visits.  In the event that a subject does not attend a scheduled visit, 
every effort will be made to reschedule.  In the event of a subject lost to 
follow-up, study exit form will be completed and efforts documented.  
 
If a subject decides to withdraw participation early, the subject will be 
requested to complete a final study visit and exit the study.  The investigator 
or sponsor may at any time during the study remove a subject if there is any 
potential safety issue or non-compliance.  In all cases, every attempt will be 
made to complete a final study visit. 
3. Outcome Measures and Assessments 
Outcome measures will be assessed around multiple endpoints.  These measures will be: 
pain, duration of improvement, anticipated observations, and safety. Additional 
assessments may also be taken but are not considered part of the analysis (i.e. subject 
post-treatment questionnaire).  The specific assessment tools, collection method and time 
points are listed herein.   
3.1.1. 
Primary Outcome Measure 
A decrease in hypertonia as measured by an improvement of 1 point or 
greater in the Modified Ashworth Scale at Day 7. 
Hypertonia will be assessed at each study time period using the Modified 
Ashworth Scale.  Assessment will be conducted by the same Investigator at 
each time point to reduce inter-assessment variation. 
3.1.2. 
Secondary Outcome Measures   
1. Improvement in spasticity as measured by the Tardieu Scale:  Subjects will 
undergo the Tardieu test to assess spasticity (verses stiffness) at each 
study visit. 
 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
2. Improvement in spasm frequency and intensity as measured by the Penn 
Spasm Score:  Subjects experiencing spasm of the upper extremity will be 
assessed using the Penn Spasm Frequency Scale at each study visit. 
 
3. Improvement in upper extremity motor recovery as measured by the Fugl-
Meyer Scale (post stroke subjects only):  Subjects who have spasticity due 
to stroke will be assessed using the Fugl-Meyer – Motor Recovery after 
Stroke Scale at each study visit. 
 
4. Subject assessed change in Mean Spasticity Numerical Rating Scale 
(NRS) Score:  Subjects will be asked "On a scale of '0 to 10' please 
indicate the average level of your spasticity over the last 24 hours" with 
the anchors: 0 = 'no spasticity' and 10 = 'worst possible spasticity'.  'No 
spasticity' is explained as the time prior to the onset of their spasticity.  
 
5. Improvement in pain as assessed by visual analogue scale (VAS):  
Subjects will be shown a number scale and six facial expressions 
suggesting various pain intensities.  The subject will be asked to choose 
the face that best describes how they feel.  The far left face indicates ‘No 
hurt’ and the far right face indicates ‘Hurts worst’.  The VAS will be 
conducted at every study visit. 
 
3.1.3. 
Ancillary Measures (Potential measures not part of analysis) 
Subject Post-Treatment Questionnaire (See Appendix) 
3.1.4. 
Anticipated Observations (AO) [Data Collection Tool] 
During each visit, the area treated will be assessed by the investigator 
(observation and subject query) for the following anticipated observations 
(AO’s) at the treatment site. These AO’s will be collected independent of 
adverse events and are specific to the treatment site area.  
• ecchymosis (bruising) 
• edema (swelling) 
• erythema (redness or inflammation) 
• pain and/or tenderness  
• localized dysesthesia (altered sensation) 
• thermal injury to the skin, skin lesions, hyper or hypo pigmentation 
secondary to skin injury 
• dimpling of skin 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
3.1.5. 
Safety Measures [Data Collection] 
Adverse events and SAEs/UADEs will be assessed at all visits.  Incidence of 
serious adverse events (SAEs) and unanticipated adverse device effects 
(UADEs) will be recorded.   
3.2. Adverse Event Reporting  
 
All adverse events, regardless of seriousness, severity, or relationship to device, will 
be recorded and evaluated by the Investigator.  The evaluation will include a 
determination of the seriousness and severity of the event, whether the event or the 
severity of the event was anticipated or unanticipated, and the relationship of the 
event to the study device. 
 
A serious adverse event (SAE) is defined according to ISO14155:2003 (section 
3.19) as any adverse event that:  
▪ Led to a death 
▪ Led to a serious deterioration in the health of the subject that 
• resulted in a life-threatening illness or injury 
• resulted in a permanent impairment of a body structure or a body 
function 
• required in-patient hospitalization or prolongation of existing 
hospitalization 
• resulted in medical or surgical intervention to prevent permanent 
impairment to body structure or a body function 
▪ Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
An unanticipated adverse device (UADE) effect is defined in 21 CFR 812.3 as 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 or application (including a supplementary plan or application), 
or any other unanticipated serious problem associated with a device that relates to 
the rights, safety, or welfare of subjects. 
 
Events NOT considered to be serious adverse events are:  
1) Hospitalizations for the treatment, which was elective or pre-planned, of a pre-
existing condition that did not worsen; and,  
2) Treatment on an emergency, outpatient basis for an event not fulfilling any of 
the definitions of “serious” given above and not resulting in hospital admission. 
Serious Adverse Events and Unanticipated Adverse Device Effects will be 
reported by the Investigator to myoscience within 24 hours and to the Institutional 

 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
Review Board (IRB) within the timeframe required by the IRB, but not more than 
7 days following the point at which the site becomes aware of the event.  
3.3. Statistical Analysis Plan 
Not applicable.   
 
4. Risk/Benefit Analysis 
4.1. Benefits 
Subjects may experience an improvement in pain and spasticity symptoms post-
treatment or may experience no improvement at all.  
4.2. Risks  
The Cryo-Touch III Device has been approved for market by the United States 
Food and Drug Administration (FDA) and the risks associated with its use are 
documented and provided in the Instructions for Use.   
 
The risks associated with this study include the use of the device in a population 
not previously studied.   
5. Study Management and Quality Control 
5.1. Data Collection 
Incoming data will be reviewed by the Sponsor or designee to identify 
inconsistent or missing data and to ensure compliance with the study protocol.    
Investigators will be responsible for the accurate and timely completion of all 
source documents, case report forms, and any other required study data (i.e., 
worksheets, questionnaires, etc.) during the trial.   
5.2. Investigator Responsibilities 
Investigators are responsible for ensuring the investigation is conducted according 
to all signed agreements, the study protocol, and applicable regulatory agency 
regulations. This section outlines- these responsibilities, although this does not 
represent a complete description of all responsibilities. 
5.2.1. 
Compliance with Good Clinical Research Practice 
This study will be conducted in compliance with the principles of the 
Declaration of Helsinki, with the current Good Clinical Practice (GCP) 
guidelines and with other applicable regulations.  The investigator and all 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
study staff will conduct the study in compliance with this protocol.  The 
protocol, informed consent documents, recruitment advertisements (if 
applicable) and any amendments to these items will have IRB approval prior 
to study initiation.  Every subject will give voluntary informed consent prior 
to the initiation of any study-related procedures.  The rights, safety and 
welfare of the study subjects are the most important considerations and 
prevail over the interests of science and society.  All personnel involved in 
the conduct of this study must be qualified by education, training and 
experience to perform their assigned responsibilities. 
5.2.2. 
Institutional Review Board (IRB) 
Before study initiation at each site, the investigator must have written and 
dated approval from the IRB for the protocol, consent form, subject 
recruitment materials/process (e.g., advertisements), and any other written 
information to be provided to subjects at his/her site. The investigator will 
submit documentation of the IRB approval to the Sponsor or designee.  
The IRB approved consent form must include all elements required by FDA, 
state, and local regulations, and may include appropriate additional elements. 
The investigator/designee will explain the study to each potential subject, and 
the subject must indicate voluntary consent by signing and dating the 
approved informed consent form.  If the subject is not able to provide written 
consent, the subject’s legal representative will consent on their behalf as 
directed by the sites IRB.  The investigator/designee must provide the subject 
with a copy of the consent form, in a language the subject understands.   
The investigator/designee will maintain documentation showing that 
informed consent was obtained prior to the initiation of any study-specific 
procedures. 
Withdrawal of IRB approval of the investigator’s part in the investigation 
shall be reported to the Sponsor within 5 working days. 
5.2.3. 
Device Accountability 
The investigator is responsible for providing a secure storage location for the 
devices, supervising device use, as well as return of the device as instructed 
by the Sponsor or designee.  In addition, investigators will maintain records 
of receipt, use or disposition of all devices.  The Sponsor or designee will 
maintain records of all shipments and disposition of the devices and will 
routinely inspect for device accountability at the clinical sites participating in 
this trial. 

 
CONFIDENTIAL & PROPRIETARY 
Page 18 of 45 
 
 
 
MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
All used units and probes shall be stored and upon request returned to the 
Sponsor or designee for analysis unless otherwise directed.  If a Sponsor 
representative or designee is present at the time of use, he/she may directly 
take possession of used device(s).  All devices will be returned to the 
Sponsor after the study is complete.   
5.2.4. 
Confidentiality 
The investigator is responsible for ensuring the confidentiality of subjects 
throughout the trial.  A unique identification code will be assigned to each 
subject participating in this trial.  Any data that may be published in 
abstracts, scientific journals, or presented at medical meetings will reference 
the unique subject code and will not reveal the subject’s identity.  
5.2.5. 
Record Retention 
The investigator must maintain all study records (including device 
disposition, informed consents, case report forms/worksheets, source 
documents, correspondence, regulatory documents, contracts etc.) for the 
maximum period required by the Sponsor or the institution where the study is 
conducted, whichever is longer. 
The investigator must contact the Sponsor prior to destroying any records 
associated with this study. 
If the investigator withdraws from the study, the records shall be transferred 
to a mutually agreed upon designee.   
5.3. Sponsor Responsibilities 
myoscience or designee’s responsibilities in the study include: 
• Developing the protocol & CRFs 
• Selecting qualified investigators (21CFR812.43(a)) 
• Maintaining Site/Investigator’s Agreement and CVs/licenses 
• Assisting sites in completing IRB approvals and reporting 
• Ensuring device availability 
• Reviewing data for study rationale and subject safety 
• Providing site training on all study aspects and procedures 
• Monitoring study data 
• Informing site(s) & IRB(s) of any new, significant safety information 
• Maintaining SOPs 
• Analyzing results and assisting with presentation(s) and/or publication(s) 
• Retaining custodianship of the multi-center clinical data generated 

 
CONFIDENTIAL & PROPRIETARY 
Page 19 of 45 
 
 
 
MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
5.3.1. 
Study Monitoring  
Representatives of the Sponsor or designee must be allowed to visit all study 
sites, to review study records and to directly compare them with source 
documents (including, but not limited to patient and hospital records), to 
discuss the study conduct with the investigator and study staff and to verify 
that the investigator, study staff, and facilities remain acceptable for the 
conduct of the study. 
Representatives of government regulatory authorities may also evaluate the 
study records, source documents, investigator, study staff, and facilities. 
The investigator should immediately notify the Sponsor or designee of any 
audits of this study by any regulatory agency, and must promptly provide 
copies of any audit reports. 
5.3.2. 
Protocol Revisions 
The Sponsor or designee must prepare all protocol revisions.  All protocol 
amendments must receive IRB approval prior to implementation.  All 
administrative letters must be submitted to the IRB for their information.  All 
correspondence with the IRB regarding this study must be maintained in the 
site regulatory file and made available to the Sponsor or designee. 
The most recent IRB approved version of the informed consent form (ICF) 
must be administered to all subjects upon enrollment.  In some cases, due to 
new information or protocol amendments, an ICF may be updated.  Subjects 
must be re-consented using the latest approved version only if directed to do 
so by the IRB and/or Sponsor. 
6. Data Ownership 
myoscience, Inc., the study Sponsor, retains ownership of all data generated in this study, 
and controls the use of the data for purposes of regulatory submissions to the United 
States and/or other governments.  Investigator(s) and institution(s) (which shall include 
their employees, agents, and representatives) may not issue or disseminate any press 
release or statement, nor initiate any communication of information regarding this study 
(written or oral) to the communications media or third parties without the prior written 
consent of myoscience.  
 
 
 

 
CONFIDENTIAL & PROPRIETARY 
Page 20 of 45 
 
 
 
MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
Appendix A: Abbreviations 
 
AE 
Adverse Event 
AO 
Anticipated Observations 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
US FDA 
United States Food and Drug Administration 
EOS 
End of Study 
FMA 
Fugl-Meyer Assessment 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonisation 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
IRB 
Institutional Review Board/Independent Review Board 
ISO 
International Organization for Standardization 
MAS 
Modified Ashworth Scale 
NRS 
Mean Spasticity Numerical Rating Scale 
NSAID 
Non-Steroidal Anti-Inflammatory Drug 
ROM 
Range of Motion 
SAE 
Serious Adverse Event 
UADE 
Unanticipated Adverse Device Effect 
ULS 
Upper Limb Spasticity 
VAS 
Visual Analog Scale 
 
 
 

 
CONFIDENTIAL & PROPRIETARY 
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MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
Appendix B: Schedule of Events   
 
 
Study Activity 
V1 
Screening 
V2 
Treatment 
V3 
V4 
 
V5 
Phone 
Follow-
up/EOS 
Day -30 to 
Day 0 
Day 0 
Day 7* 
Day 
30** 
Day 56** 
Obtain Informed Consent 
X 
 
 
 
 
Review Eligibility Criteria 
X 
X 
 
 
 
Physical Examination 
X 
 
 
 
 
Medical History 
X 
X 
 
 
 
Concomitant Medications/Procedures 
X 
X 
X 
X 
X 
Modified Ashworth Scale 
X 
X 
X 
X 
 
Tardieu Scale  
X 
X 
X 
X 
 
Penn Spasm Frequency Score 
X 
X 
X 
X 
 
Fugl-Meyer Assessment (Post Stroke Only) 
X 
X 
X 
X 
 
Visual Analog Scale (VAS) For Pain 
X 
X1 
X 
X 
 
Mean Spasticity Numerical Rating Scale 
(Nrs) 
X 
X 
X 
X 
 
Treatment 
 
X 
 
 
 
AO Assessment 
 
X 
X 
X 
X 
Subject Post-Treatment Questionnaire 
 
X 
X 
X 
 
Adverse Events/Procedures Review 
 
X 
X 
X 
X 
Duration Of Treatment Effect/No Effect 
 
 
X 
X 
X 
* A variance of +/- 3 days is allowed. 
** A variance of +/- 7 days is allowed. 
1VAS assessment for pain at Visit 2 should be taken pre-treatment and post-treatment 
 
 

 
CONFIDENTIAL & PROPRIETARY 
Page 22 of 45 
 
 
 
MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
Appendix C:  Validated Assessment Tools 

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CONFIDENTIAL & PROPRIETARY 
Page 43 of 45 
 
 
 
MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
Pain Visual Analog Scale 
 
 
Instructions: Adults may have difficulty using a number scale and may be assisted with the 
use of the six facial expressions suggesting various pain intensities.  Ask the subject to choose 
the face that best describes how they feel.  The far left face indicates ‘No hurt’ and the far 
right face indicates ‘hurts worst’.  Document number below the face chosen. 
 
Faces rating scale (FRS) 
 

 
CONFIDENTIAL & PROPRIETARY 
Page 44 of 45 
 
 
 
MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
Mean Spasticity Numerical Rating Scale (NRS) Score 
 
Instructions:   Subjects will be asked "On a scale of '0 to 10' please indicate the average level of 
your spasticity over the last 24 hours" with the anchors: 0 = 'no spasticity' and 10 = 'worst possible 
spasticity'.  'No spasticity' is explained as the time prior to the onset of their spasticity. 
 
Visual Scale 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
No 
spasticity 
 
 
 
Moderate 
spasticity 
 
 
 
 
Worst 
possible 
spasticity 

 
CONFIDENTIAL & PROPRIETARY 
Page 45 of 45 
 
 
 
MYO-0709: A Prospective, Non-Randomized, Unblinded Study Evaluating the Treatment with the Cryo-
Touch III Device For Upper Limb Spasticity 
 Appendix D: Subject Post-Treatment Questionnaire 
  
Instructions: To better help the sponsor understand the dynamics of the treatment the 
following questions have been compiled.  The investigator, or designee, will request a response 
from the subject at the designated time and complete the source document as appropriate.  If no 
response or not applicable check the appropriate box.  
 
Day 0/Visit 2/Post-Treatment 
 
1. How nervous were you during the procedure?  On a scale from 1-5, 1 being extremely 
nervous and 5 being completely relaxed.  
2. Prior to your treatment today, how effective or helpful was the information provided 
beforehand (information pamphlet, informed consent, etc.)? On a scale from 1-5, 1 being 
not at all effective/helpful to 5 being very effective/helpful.  
3. Was the treatment painful?  On a scale from 1-5, 1 being not at all painful to 5 being very 
painful.  
 
Visit 3/Day 7 and Visit 4/Day 30 
 
1. If you had any anticipated observations (AO) from your treatment (i.e., bruising, 
swelling), how much did they/it impact your daily routine?  On a scale from 1-5, 1 being 
the AO had a very negative impact to 5 being no impact at all. 
2. Would you recommend this treatment to a friend or family member? Yes or No.  
3. Would you have the treatment again if available? Yes or No.  
4. Is there any pain present from the treatment?  On a scale from 1-5, 1 being not at all 
painful to 5 being very painful.