STOP-TIC Study: Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT
Phase: NA
Conditions: Tourette Syndrome
Sponsor: University of Florida

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IRB Research Protocol 
Title: STOP-TIC Study: Strengthening Tourette Treatment OPtions Using TMS to Improve CBIT 
NCT: 04795908 
*Please note this is the original IRB document with the intended plan.  
Background: Tourette Syndrome (TS) is characterized by multiple motor and at least one vocal tic persisting 
for at least one year.”1,2 Up to 20% of patients with TS have persistent tics during adulthood.2,3 These tics can 
lead to impaired quality of life, social embarrassment, dysfunction in completing daily tasks, and complex tics 
can lead to pain or injuries.4,5 Current treatments for TS have limitations: pharmacologic treatments are limited 
by their side effect profile and incomplete efficacy, and the evolving therapy of deep brain stimulation is an 
invasive surgery and not appropriate or feasible for most TS patients.5-7 Comprehensive behavioral 
intervention for tics (CBIT) is an effective intervention for TS8-10; however, randomized controlled studies have 
shown less than 40% reduction of tic symptoms in adult patients with TS.10-12 Therefore, there is a critical need 
to potentiate the benefits of CBIT, in order to open the door for innovative treatments that can improve the 
quality of life for patients with TS.  
Transcranial magnetic stimulation (TMS) is a painless and non-invasive neuromodulation technique that uses a 
magnetic field to induce a cortically based electric field. TMS pulses delivered on a repetitive basis, known as 
repetitive TMS (rTMS), can modulate the brain networks involved in TS and potentially lead to clinical 
improvements. rTMS delivered at low-frequency (≤ 1 Hz) mimics long-term depression, leading to decreased 
cortical excitability. In contrast, high-frequency TMS (> 5 Hz) mimics long-term potentiation, leading to 
increased cortical excitability.13 Further, rTMS delivered over multiple sessions has cumulative benefits that 
last beyond the stimulation period.13,14 The pathophysiology of TS is still not fully understood. Singe-pulse and 
paired-pulse TMS studies in adults with TS have revealed normal resting motor threshold (RMT), shortened 
cortical silent period (CSP), and reduced short-interval intracortical inhibition (SICI), implicating cortical 
hyperexcitability as a potential mechanism for TS.15-20  Functional MRI studies have shown that increased 
activity of the network connecting the cortex, striatum and the thalamus leads to more severe tics.6,7,15,21-24 In 
addition, these imaging studies have shown that the supplementary motor area (SMA) is often hyperactive just 
prior to a tic occurrence.6,24-26 The SMA is highly interconnected with the networks involved in the production of 
tics and is located superficially, allowing for penetrance by rTMS. The SMA is thus an ideal neuromodulation 
target for the TS population.15 
There is emerging data from case reports, open-label studies, and small randomized controlled trials to that 
low-frequency rTMS targeted to the SMA can lead to tic reduction.27-34 However, these studies are small, many 
involved only a single stimulation session, and the follow-up period was limited. Furthermore, these studies did 
not investigate whether rTMS in conjunction with CBIT could lead to synergistic benefits. rTMS is postulated to 
enhance motor and cognitive learning through the Hebbian mechanisms of neuroplasticity.35-37 Thus, when 
rTMS is used in conjunction with behavioral and cognitive therapies, it may potentiate the synapses that are 
recruited to complete the intended tasks.35,37 Therefore, the primary goal of this proposal will be to determine 
whether low-frequency rTMS delivered to the SMA has synergism with CBIT therapy in patients with TS. The 
central hypothesis of the proposal is that rTMS will potentiate the effects of CBIT, resulting in improved 
outcomes in patients with TS. In addition, given the known benefits of rTMS on depression and obsessive-
compulsive disorder (OCD)38,39, it is hypothesized that rTMS plus CBIT may not only lead to tic improvement, 
but also result in improvement in comorbid depression and OCD symptoms observed in patients with TS. 
Since CBIT and rTMS both typically require multiple sessions over several weeks to be effective, these could 
present barriers to patient compliance. Delivering CBIT therapy via a virtual platform is just as effective via 
telehealth as it is in-person.40,41 Accelerated rTMS protocols which condense the number of sessions into a 
consecutive day paradigm have been successfully and safely employed in other patient populations.42-45 
Therefore, a consecutive 4-day accelerated rTMS protocol followed by the recommended protocol for CBIT of 
8 sessions in 10 weeks using a virtual platform will be implemented to mitigate these logistical challenges.  
 
 

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This will be an open-label study for which all subjects with receive active rTMS. Following active rTMS, all 
participants will undergo 10 weeks of tele-CBIT and whether rTMS will augment the effects of CBIT will be 
determined (Aim 1). The effects at baseline (T0), after rTMS (T1), and after CBIT therapy (T2)will be measured 
(Figure 1). In addition to the clinical outcomes, the physiological changes underlying the clinical effects will be 
investigated (Aim 2).  
OBJECTIVES/SPECIFIC AIMS: 
Specific Aim #1: Determine the clinical effects of rTMS combined with CBIT in TS. 
The clinical effects of active rTMS + CBIT on tics and comorbid nonmotor symptoms will be determined. Tics 
will be examined with the standardized Yale Global Tic Severity Scale (YGTSS) and the modified Rush 
Videotape Tic Rating Scale (mRVTRS), and co-morbid symptoms with the Beck Depression Inventory (BDI), 
Beck Anxiety Inventory (BAI), Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and Adult ADHD Self-
Reports Scale (ASRS). Quality of life will be assessed with the Gilles de la Tourette Syndrome – Quality of Life 
scale (GTS-QOL). I hypothesize that compared to baseline (T0), there will be greater reduction in tics (Aim 1a) 
and associated co-morbid symptoms and improvement of quality of life (Aim 1b) at T1 and T2 . I also 
hypothesize that the accelerated protocol will be safe and well tolerated in this patient population (Aim 1c).  
Specific Aim #2: Determine the physiological effects of rTMS combined with CBIT in TS.   
The physiological effects of active rTMS + CBIT will be determined using TMS and fMRI techniques. Cortical 
excitability will be determined with established TMS single and paired pulse paradigms including RMT, CSP, 
and SICI (Aim 2a), and resting state fMRI will be used to monitor the blood oxygen level dependent (BOLD) 
activity and connectivity of the SMA (Aim 2b). I hypothesize that the change in TMS measures will significantly 
improve and BOLD activity on fMRI will decrease over SMA at T1 and T2, compared to baseline and will 
correlate with the clinical improvements as outlined in Specific Aim #1.  
RESEARCH PLAN AND METHODOLOGY: Patients with a diagnosis of Tourette’s syndrome at our 
movement disorders center will be enrolled. Diagnosis of TS will be established in accordance with the 
Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).  
 
Inclusion Criteria: Any patient diagnosed with Tourette Syndrome > 18 years of age with moderate tic 
severity. Participants will be allowed to continue oral medications that they are taking for TS concurrently but 
will not be allowed to change their concurrent medication regimen throughout the duration of the study. 
Exclusion Criteria: 1) Presence of metallic objects or neurostimulators in the brain, 2) pregnancy, 3) history of 
active seizures or epilepsy, 4) contraindications to receiving fMRI, such as claustrophobia 5) inability to 
participate in CBIT due to other underlying cognitive or medical condition  
 
Enrollment: Our target is to enroll 20 total 
patients in the study. In order to enroll 20, we 
will need to screen more than that number. 
We anticipate that we will need to screen 64 
patients in order to find 24 that are eligible for 
enrollment. Of those 24, we anticipate that 4 
will choose not to participate in the study.  
IRB approved informed consent will be 
obtained. The study procedures will be 
explained, and subjects will have a detailed 
medical history and neurological examination.  
Patients will have primary and secondary 
outcome measures performed at four time 
points: Baseline (T0), following rTMS (T1), and following CBIT (T2)(Figure 1). The study protocol will take 
place over approximately 11-12 weeks. Details of specific parts of the protocol are included below.  
 
           
         
T1
 efore rT   
 linical  T    f   
         
         
       
            
sta le doses of 
medications  
moderate tic 
se erity
T 
T 
           tudy design and timeline. T   atients with moderate se erity sym toms will 
 e randomized to two grou s of acti e rT       T or sham rT       T.  linical  
 hysiology measures  and imaging will  e collected at four time  oints ( aseline T   
T1  T   T ).
    
 fter rT   
 linical  T    f   
 fter    T
 linical  T    f   
    
1 month follow  u  
 linical  T    f   
T 
1 wee 
 wee s
1 wee s

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Primary Outcome: Tic severity will be measured with YGTSS and mRVTRS. Videos of participants will be 
recorded at T0, T1, and T2,which will be scored by two independent blinded raters.  
Secondary Outcomes: BDI, BAI, Y-BOCS, ASRS, and GTS-QOL; TMS, EEG, and fMRI outcomes.  
 
 
 
rTMS protocol: rTMS will be delivered using a NeuroStar TMS therapy system (Neuronetics, Malvern, PA). 
The resting motor threshold (  T) will  e defined as the lowest stimulation intensity required to e o e a 5  μV 
potential in a target muscle (i.e. first dorsal interosseus muscle/FDI). A figure of eight coil will be used to deliver 
the stimulation. Patients will be seated in a comfortable reclined chair. The neurostimulation protocol will 
include 1-Hz rTMS over the bilateral SMA at 110% RMT. The SMA will be identified as 4 cm anterior to the 
vertex (Cz in standard 10-20 EEG setup). Each session will consist of 6 trains lasting 5 minutes each (300 
pulses per train) with an intertrain interval of 1 minute for a total duration of 35 minutes (1800 pulses). Patients 
will receive 4 sessions 
each day on 4 
consecutive days for a 
total of 16 sessions.  
Daily duration of this 
study protocol should 
last approximately 
170 minutes including 
a 10 minute break in 
between each session 
(Figure 2). Constant coil position will be continuously monitored during the experiment. During rTMS, all 
participants will wear earplugs in order to protect the ears from the acoustic artefact associated with the 
discharge of the stimulation coil.  
 
 
Single and paired-pulse TMS paradigms: The single and paired-pulse paradigms will be performed using 
the MagStim Bistim unit, which will be in the same room as the NeuroStar TMS machine. These will be 
followed per established protocols in the literature (Figure 3 A and C)14,34 A single-pulse of TMS will be targeted 
over the motor cortex to generate a motor evoked potential (MEP), which can be captured on EMG. The rest of 
the EMG will be analyzed to assess the time between the TMS pulse and the MEP (also known as the latency) 
and the amount of time muscle activity remains silent following the MEP (also known as the cortical silent 
period). In a paired-pulse TMS paradigm, a subthreshold pulse will be provided followed by an interstimulus 
interval and then subsequent delivery of a suprathreshold pulse. When the interstimulus interval is short (1-4 
msec), the ratio of MEP amplitudes produced by these two pulses is known as short interval intracortical 
inhibition (SICI). 
 
fMRI protocol: Functional MRI will be used to record Blood Oxygen Level Dependent (BOLD) activity changes 
in patients at rest, using protocols similar to other studies in the literature in the TS population34, as well as 
fMRI studies conducted by our group in other movement disorder populations.46 The fMRI procedure should 
last approximately 1 hour. A 32-channel head coil will be used on a 3T MRI scanner. Subjects will wear 
earplugs during the sessions to minimize discomfort due to scanner noise. Anatomical images will be acquired 
in 170 contiguous axial slices at 1×1×1 mm resolution with a T1- weighted fast spoiled gradient-recalled 
sequence (repetition time (TR) = 6.8 ms; echo time (TE) = 3.3 ms; flip angle = 8º). Task-based functional MRI 
will be acquired in 46 axial slices at 3×3×3 mm resolution using a single-shot gradient echo-planar imaging 
pulse sequence (TR = 2500 ms; TE = 30 ms; flip angle = 80º). Each functional scan will include 176 TR 
 olumes.  ushions will  e  laced in the head coil around the su ject’s head to minimize head-motion with 
strapping if needed. Repetition times (TRs), that include head motion exceeding 0.5 mm from TR to TR, will be 
excluded. Open source platform Analysis of Functional NeuroImages (AFNI: Version 16.0.19) will be used for 
the whole brain analysis. A combined 1.0-mm motion exclusion criterion in the x-, y-, and z-planes will be used. 
The following preprocessing steps will be followed. The first three functional MRI volumes will be removed to 
  
1 train = 300 pulses over 5 minutes 
1 train = 300 pulses over 5 minutes 
ITI =  
1 min
ITI =  
1 min
ITI =  
1 min
Figure 2. A schematic drawing representing a portion of an rTMS session. Each train consists of 300 pulses over 5 minutes (blue) and 
each intertrain interval (ITI) lasts for 1 minute without pulses (orange). Each session contains 6 trains alternating with an ITI. Patients 
will undergo 4 sessions per day, to be repeated for 4 consecutive days. 

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account for scanner magnetization equilibrium. Following that slice-timing correction, rigid-body volume 
registration, co-registration of the functional MRI scan to the T1-weighted anatomical scan, non-linear spatial 
warping of the functional MRI scan to the MNIavg152 template will be performed. Signal-to-noise ratio will be 
improved by spatial smoothing using a full-width at half-maximum Gaussian kernel of 8mm.  
 
CBIT protocol: All CBIT sessions will be conducted by an occupational therapist (Heather Simpson, OTD, 
OTR/L) who is a certified therapist in CBIT. Patients will have the option of having the first introductory CBIT 
sessions scheduled in-person since they will already be at the center for rTMS and outcome measures. For 
convenience, all other CBIT sessions will occur through a secure telemedicine platform. Each CBIT session 
will last approximately 1 hour. Following CBIT protocol, there will be 8-10 tele-CBIT sessions over 10 weeks, at 
the thera ist’s discretion. Each session will  e indi idualized to each  atient’s needs de ending on tic ty e and 
severity.  
 
EEG protocol: High-Density EEG using 128 electrodes as the setup will be implemented. Each EEG session 
should last about 1 hour. Patients will be seated comfortably in a chair and a cap will be stretched across the 
scalp. This cap has 128 contacts where the electrodes will be connected using biosoluble glue. The electrodes 
will be placed appropriately by a clinician or technician trained to place the EEG electrodes. The  atient’s 
electrical activity will be recorded under two conditions: at rest and asking the patients to voluntarily suppress 
their tics (Figure 3B and D).  
 
 
Safety: Since the most important safety concern with rTMS is the possibility of seizure, participants with active 
seizure disorder or those at increased risk of seizure will be excluded. Low frequency protocols carry less risk 
of seizure as compared to high frequency protocols given that high frequency generates cortical excitability.47 
In spite of the theoretically increased risk of seizure in accelerated rTMS protocols, several accelerated high-
frequency protocols have been safely performed in other patient populations and have been tolerated well by 
patients without evidence of increased adverse events.42-45 A similar protocol to the one proposed in this study, 
using the same TMS system that I will  e using  has  een safely com leted in the  ediatric Tourette’s 
population.34 Patients will be screened prior to admission into the study, and those at risk for adverse reactions 
will be excluded. Those selected for participation will be monitored closely for adverse events. Other mild side 
effects that participants may experience secondary to TMS include transient eye pain, toothache, muscle twitch, 
facial pain, neck stiffness, and pain or discomfort at the application site and skin.  

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Clinical Assessments: 
Yale Global Tic Severity Scale (YGTSS): This is a tool used to quantify the severity of tics through a semi-
structured interview by assessing 5 components: number, frequency, intensity, complexity, and interference.   
Modified Rush Videotape Tic Rating Scale (mRVTRS): This is a tool used by an objective examiner to quantify 
the se erity of a  atient’s tics  y rating the num er of  ody areas affected  motor tic frequency   honic tic 
frequency, motor tic severity, and phonic tic severity, each on a 0 through 4 score by watching a video of the 
patient.  
Beck Depression Inventory (BDI): This is a 21-question survey evaluating depression in patients on a 0 to 3 
scale.  
Beck Anxiety Inventory (BAI): This is a 21-question survey evaluation anxiety in patients on a 0 to 3 scale.  
Yale-Brown Obsessive Compulsive Scale (Y-BOCS): This is a 10 question survey which rates components of 
obsessive thoughts or compulsive behavior and each question is rated on a 0 through 4 scale.  
Adult ADHD Self-Report Scale (ASRS): This is an 18-question survey which asks patients to rate levels of 
attention, concentration, and organization as applied to daily tasks.  
Gilles de la Tourette Syndrome – Quality of Life scale (GTS-QOL): This is a 27-question survey that asks patients 
to rate how their tics and abnormal movements affect their quality of life.  
Patients will have primary and secondary outcome measures performed at four timepoints: Baseline (T0), 
following rTMS (T1), and following CBIT (T2).The study protocol will take place over approximately 11-12 
weeks. All events related to the study procedure will take place within +/- 14 days of the expected timeline, with 
more details below (Figure 4). Patients will be compensated for their hotel stay during the 4 consecutive days 
of rTMS, and they will also receive compensation following completion of their time in the study in its entirety.  
 
Figure 4. Timeline of study events and expected study activities at each timepoint.  
 
Study Events 
(to occur +/- 
14 days) 
Screening 
Baseline 
(T0) 
rTMS 
protocol (4 
days) 
Post-TMS 
(T1) 
CBIT (10 
weeks) 
Post-
CBIT (T2) 
Informed 
Consent 
 
 
 
 
 
 
Medical 
History 
 
 
 
 
 
 
Neurologic 
Exam 
 
 
 
 
 
 
Pregnancy 
Test (if 
woman of 
childbearing 
age) 
 
 
 
 
 
 
Demographics  
 
 
 
 
 
Active rTMS 
 
 
 
 
 
 
Tele-CBIT 
 
 
 
 
 
 
YGTSS 
 
 
 
 
 
 
mRVTRS 
 
 
 
 
 
 
BDI 
 
 
 
 
 
 
BAI 
 
 
 
 
 
 

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Y-BOCS 
 
 
 
 
 
 
ASRS 
 
 
 
 
 
 
GTS-QOL 
 
 
 
 
 
 
MEP 
 
 
 
 
 
 
CSP 
 
 
 
 
 
 
SICI 
 
 
 
 
 
 
HD-EEG 
 
 
 
 
 
 
fMRI 
 
 
 
 
 
 
Study 
Compensation 
 
 
 
 
 
 
 
In order to participate in the study, patients will need to be present at the Fixel Neurologic Institute/University of 
Florida for 5 consecutive days at the beginning of the study, and will have to return in person for a single day 
after the 10 weeks of tele-CBIT.  
 
Compensation: 
Participants will receive $60 for taking part in the study (compensation for their participation)- this 
compensation will be prorated, so that patients will receive $20 in 3 equal installments, correlating with the T0, 
T1, and T2 outcome measure time periods.  
Reimbursement: 
In addition, participants who live a minimum of 50 miles from Gainesville will be offered a 4-night hotel stay of 
up to $125 per night in Gainesville so that they can complete the 5 consecutive days at the beginning of the 
study without having to travel back home each night- this will be paid at the time the patient and family are 
staying at the hotel. Participants (and family members/caregivers who accompany them) will additionally be 
compensated up to $150 ($75 for gas and $75 for food) during their visits to the Fixel Center/UF related to 
participation in this study. This will also be prorated so that they will receive $25 for gas and $25 for food in 3 
equal installments at each of the outcome measure timepoints: T0, T1, and T2. 
 
Data Safety Monitoring Plan: The research team monitors the patient safety and data collection of each 
study visit.  The Data Safety and Monitoring Committee will meet once each year to review the recruitment, 
adverse events, data collection, and other aspects of the study.  The Data Safety and Monitoring Committee 
will be notified of any adverse events that occur during the course of the study, within 2 business days of the 
specific adverse event.  This will allow the DSMC to review any issues that arise in a timely manner.  Breaches 
of confidentiality will also be monitored by the DSMC.  If there is possible harm to subject safety or the 
possibility of, any harm due to something new that was learned during the study, the DSMC will be 
convened.  If there is possible harm to subject safety or the possibility of, any harm due to something new that 
was learned during the study, the DSMC will be convened. Irene Malaty, M.D., Ashley Rawls MD, and Aparna 
Wagle Shukla MD will monitor the safety of the project yearly. Dr. Rawls will serve as an independent health 
professional on the Data Safety Monitoring Committee.  
Location: The clinical portions of the study will be performed at the Fixel Neurological Institute; patients will 
have the clinical outcome measures collected in a clinic or research room.  
The NeuroStar TMS machine is located in a separate TMS room within the Fixel Neurologic Institute. The 
MagStim Bistim machine is located in the same room.  
Other devices necessary to complete the study include these portable devices which will reside in the TMS 
room during the study procedure: 
EMG system: Bagnoli™ Desktop EMG system (Delsys, Inc., Boston, Massachusetts). It includes four surface 
electrodes to detect muscle movement  
EEG system: ActiveTwo system (Biosemi, Amsterdam, Netherlands). It has a cap with electrodes in a 
preconfigured montage, using 128 Ag-AgCl electrodes. 

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The McKnight Brain Institute houses two 3 Tesla fMRI scanners for clinical research use, and is about a 10 
minute drive from the Fixel Neurologic Institute.  
 
Possible Discomforts and Risks: There are some possible discomforts and risks for participants taking part in 
this study, most of which are mild or transiently related to the study protocol and will abate afterwards. 
TMS: 
• 
Headaches – Headaches and neck aches can occur. They can be related to stabilizing the neck when 
measuring TMS. They are usually short lasting and respond easily to over the counter analgesics. 
• 
Transient hearing threshold shift – There is a possibility of temporary mild hearing loss due to the noise of the 
TMS machine. The rate of this risk is unknown yet. Earplugs will be provided to the participant to reduce the 
potential for this risk.   
• 
Seizure – A theoretical risk associated with brain stimulation. Since FDA clearance of TMS, the seizure risk is 
≤ .1%  er  atient (less than 1 in 1     atients).   n the e ent that the  artici ant has a seizure  the study 
staff will immediately stop the treatment session and make sure that the participant is safe during the seizure.  
The participant will be watched for a period of time after the seizure to make sure he or she is feeling well. 
Individuals with an active seizure disorder are excluded. 
• 
Fainting – Not directly related to magnetic stimulation. It is thought to be related to anxiety and psycho-
physical discomfort during the procedure. The laboratory is equipped, and staff is trained to respond to this 
risk if fainting occurs. However, the participant will be at very low risk (less than 1%) for fainting. Transfer to 
the emergency room might be needed if the participant fails to improve as expected. 
• 
Effect of Magnetic Stimulation – Effect described on implanted devices (such as pacemakers, deep brain 
stimulation leads or cochlear implants). To avoid this potential complication, the participant will be excluded 
from the study if the participant has any metallic implants such as pacemakers, implants, metal rods or 
hearing aids.  
• 
Childbearing Potential- There may be unknown risks to the fetus. Therefore, women of childbearing age will 
complete a pregnancy test for the TMS portion of the study at each visit. In order for the women of 
childbearing age to participate in this study, the participant should avoid becoming pregnant from their first 
day of most recent menses.  A negative pregnancy test does not absolutely prove that a woman is not 
pregnant.  If the female participant thinks that there is a possibility that she might be pregnant, the study team 
should be notified immediately. Nursing mothers are not eligible for participation in this project.  The 
possibility exists that complications and undesirable side effects, which are unknown at this time, could occur.   
EEG: 
• 
A gel paste is used to attach the sensors during EEG which may mildly and briefly irritate the skin on the 
scalp or face. Hair products cannot be used on the day of testing (or should be washed out prior to testing), 
which may be inconvenient to the participant. 
fMRI: 
 
• 
Patients will need to lie flat for an extended period of time in a relatively enclosed space which may be 
uncomfortable for some patients. However, when safety guidelines are followed, an fMRI has minimal to no 
risk for the average patient. These rare risks include an allergic reaction to the IV gadolinium contrast used 
during the study and nephrogenic systemic fibrosis in patients with severe kidney disease. Patients with 
contraindications to fMRI, including documented gadolinium contrast allergy resulting in anaphylaxis, 

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severe kidney disease, or implanted medical devices incompatible with fMRI will be excluded from the 
study.  
 
Possible Benefits: The participant may or may not benefit from taking part in the study. All participants will 
undergo CBIT, which has previously been studied and is one of the first-line treatments for TS given its favorable 
efficacy11,48-49, so participants may benefit from participation in CBIT. Half the subjects will receive active rTMS 
which may augment the CBIT sessions, leading to even further reductions in tic severity and frequency. The 
information gathered from this study will benefit the neurology department and the larger research community 
as we continue to see  the most efficacious treatments for Tourette’s  yndrome.  
Regulatory Approval and Statistics: The study will be approved by the University of Florida Institutional Review 
Board, and all subjects will provide written informed consent. The study is highly feasible given the relatively 
large num er of  atients with Tourette’s that are seen at UF. This is a pilot study so it has not been powered for 
statistical significance. We will use descriptive statistics and ANOVA to run analysis on the data that has been 
collected.  
Confidentiality: Information collected about the patient will be stored in locked filing cabinets or in computers 
with security passwords.  Only certain people have the legal right to review these research records, and they will 
protect the secrecy (confidentiality) of these records as much as the law allows. These people include the 
researchers for this study, certain University of Florida officials, the hospital or clinic (if any) involved in this 
research, and the Institutional Review Board (IRB; an IRB is a group of people who are responsible for looking 
after the rights and welfare of people taking part in research). Otherwise the research records will not be 
released without participant permission unless required by law or a court order. 
 
Researchers will take appropriate steps to protect any information they collect about participants. However, 
there is a slight risk that information about participants could be revealed inappropriately or accidentally.  
Depending on the nature of the information such a release could upset or embarrass them, or possibly even 
affect their insurability or employability.   
 
If the results of this research are published or presented at scientific meetings, patient identity will not be 
disclosed. 
 
Depression measure and suicide risk: If the Beck Depression Inventory reveals that the patient has feelings 
of harming themselves (Question 9 score 2 or above), we will refer them to mental health services available at 
Shands at the University of Florida. 
References: 
 
1. Robertson MM, Eapen V, Singer HS, Martino D, Scharf JM, Paschou P, Ressner V, Woods DW, Hariz 
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Primers 2017;3:16097. 
2. Novotny M, Valis M, Klimova B. Tourette syndrome: a mini-review. Front Neurol 2018;9:139. 
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6. Hsu CW, Wang LJ, Lin PY. Efficacy of repetitive transcranial magnetic stimulation for Tourette 
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