Tourette SyndromeMBITNCT06408662
Remote Delivery of a Mindfulness-based Intervention for Tics
A study testing mindfulness-based intervention for tics (MBIT) and psychoeducation with relaxation and supportive therapy (PRST) in people with Tourette Syndrome and Tourette's Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research study is being done to compare a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) for individuals with Tourette's syndrome or Persistent Tic Disorders (collectively TS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome, Tourette's Disorder, Chronic Motor Tic Disorder
- What is being tested?
- mindfulness-based intervention for tics (MBIT) and psychoeducation with relaxation and supportive therapy (PRST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be ≥18 years of age;
- meet diagnostic criteria for a primary or co-primary diagnosis of Tourette Syndrome or a Persistent Motor or Vocal Tic Disorder on a structured clinical interview;
- have moderate or greater tic severity as evidenced by a YGTSS Total Tic Score of >14 (when motor and vocal tics are present) or >10 (when only motor or vocal tics are present);
- be medication free and/or on a stable dose of psychiatric medication 8 weeks prior to study participation;
- be not engaged in psychotherapy for non-TS conditions and/or be on a stable course of therapy for 6 months prior to study participation
- be fluent in English;
- have access to a smart phone and/or tablet.
Who cannot join
- a current diagnosis of substance use disorder, psychosis, mania or another condition that requires another form of care;
- severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention;
- concurrent psychotherapy for TS;
- prior extensive experience with mindfulness and/or meditation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Joseph F McGuire, PhD, 443-300-8836, mbit@jh.edu
Joseph F. McGuire, PhD
About this study
This research study is being done to compare a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) for individuals with Tourette's syndrome or Persistent Tic Disorders (collectively TS). It is the investigator's hope that this information cam be used to improve current treatments for individuals with TS.
Read the detailed description
Tourette's syndrome and other persistent tic disorders (collectively, TS) is a condition that onsets in childhood and affects ~1% of the population. Alongside motor and vocal tics, patients with TS experience distressing somatosensory sensations (i.e., premonitory urges) and co-occurring mental health conditions such as anxiety disorders, depressive disorders, obsessive-compulsive disorder (OCD), and ADHD. Tics and comorbid symptoms cause individuals with TS significant distress and impairment across life domains (e.g., physical, social, academic, occupational, emotional, and familial). Two evidence-based treatments exist for TS: behavior therapy and pharmacotherapy. Behavior therapy [often referred to as habit reversal training (HRT) or the comprehensive behavioral intervention for tics (CBIT)] is an evidence-based treatment that has been shown to reduce the severity of tic symptoms, and has a low risk for adverse effects. Although behavior therapy is recognized as a first-line intervention for TS, less than 40% of adults with TS respond to this evidence-based treatment. Additionally, current behavioral interventions are often inaccessible for adults with TS. While pharmacotherapy for tic management (e.g., antipsychotic medications) has been shown to be effective, these treatments can have adverse side effects with detrimental health consequences. Thus, there is a critical need for new treatments for adults with TS that are efficacious for reducing tic severity, beneficial for co-occurring conditions, and have few adverse health effects. Mindfulness-based interventions have proven beneficial for adults with a wide range of neuropsychiatric conditions. Based on the investigator's prior work, the investigators believe that a mindfulness-based intervention for tics (MBIT) is beneficial for adults with TS.
This project is a randomized controlled trial (RCT) that will compare the efficacy of a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth services platforms and online electronic data capture systems. An independent evaluator (IE) masked to treatment condition will administer all assessments during the treatment and follow-up periods. The investigators will test the mechanisms by which MBIT reduces tic severity, and examine the efficacy of MBIT relative to PRST for common co-occurring psychiatric symptoms and quality of life impairments-towards "treating the whole person". Finally, the investigators will explore the sustained therapeutic improvement from MBIT over a 6-month follow-up period focusing on tic severity, tic-related impairment, co-occurring psychiatric symptoms, and quality of life.
- Conditions
- Tourette Syndrome, Tourette's Disorder, Chronic Motor Tic Disorder, Chronic Vocal Tic Disorder, Persistent Motor Tic Disorder, Persistent Vocal Tic Disorder
- Being tested
- mindfulness-based intervention for tics (MBIT), psychoeducation with relaxation and supportive therapy (PRST)
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based intervention for tics (MBIT)Other
Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practice
psychoeducation with relaxation and supportive therapy (PRST)Other
Psychological Intervention that focuses on learning more about tics, practicing a range of strategies for coping with tics (e.g., relaxation, effective communication), and discussing challenges commonly experienced by individuals with tics.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based intervention for tics (MBIT) | Experimental | This is an 8-week mindfulness-based group intervention delivered via telehealth. It consists of mindfulness and meditative practice, didactics, inquiry, discussion and weekly therapeutic exercises and assignments (i.e., homework). Receives: Other: mindfulness-based intervention for tics (MBIT) |
| psychoeducation with relaxation and supportive therapy (PRST) | Active comparator | This is an 8-week educational and supportive therapy group intervention delivered via telehealth. It consists of psychoeducation, relaxation, discussion, and weekly therapeutic exercises and assignments (i.e., homework). Receives: Other: psychoeducation with relaxation and supportive therapy (PRST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
The YGTSS is a clinician-administered measure of tic symptom severity (0-50) and impairment (0-50). Greater scores are reflective of greater severity and/or impairment.
Measured: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Secondary outcomes (11)
Clinical Global Impressions Scales of Severity and Improvement (CGI-S & CGI-I)
In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved).
Measured: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Adult Tic Questionnaire (ATQ)
Higher ATQ scores reflect a worse outcome. For each tic present in the past week, its severity score is the sum of its frequency score (0-4, 4 worst, occurring "almost all the time during the day") and its intensity score (0-4, 4 worst). The ATQ severity score is the sum of the severity score for each of up to 27 tics present in the past week. The minimum possible severity score on the ATQ is 0, indicating that no tics were present in the past week. The maximum possible severity score on the ATQ indicates is 216, indicating that a tic of each of the 27 types listed was present in the past week, each with an item severity score of 8 = 4 + 4.
Measured: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Yale-Brown Obsessive Compulsive Scale-II
A clinician-administered measure of OCD severity that has shown good psychometric properties. The total score ranges from 0 to 50, with greater total score reflective of greater severity.
Measured: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Attention-Deficit Hyperactivity Rating Scale (ADHD-RS)
A self-report measure of ADHD severity that has shown good psychometric properties in TS studies. The total score ranges from 0 to 72, with greater scores indicating greater ADHD severity.
Measured: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Patient Health Questionnaire-9 (PHQ-9)
A self-report measure of depressive symptom severity (range: 0-27), with greater total score reflecting greater depressive severity.
Measured: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Premonitory Urge to Tic Scale (PUTS)
A self-report measure of premonitory urges (range: 0-36), with a greater total score reflective of greater premonitory urges.
Measured: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Five Facet Mindfulness Questionnaire (FFMQ)
Each item is rated on a 1 to 5 scale with 1=never or very rarely true and 5=very often or always true; responses are summed and then divided by 39 (the number of items). Higher scores on the FFMQ reflects a higher level of mindfulness (a better outcome).
Measured: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Client Satisfaction Questionnaire
An 8-item self-report measure assessing client's satisfaction with treatment services. The total score ranges from 8 to 32. Greater total score corresponds with greater satisfaction with services
Measured: Post-treatment (Week 9)
Self Compassion Scale
Measure ranges from 26 to 130, with higher scores indicating higher levels of self-compassion
Measured: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Affective Reactivity Index
A 6-item scale of affective reactivity that ranges from 0-12, with higher scores reflective of greater affective reactivity.
Measured: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Brief Irritability Test
A five-item self-report measure of irritability that ranges from 5 to 30, with greater scores reflective of greater irritability.
Measured: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start23 May 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project is a randomized controlled trial (RCT) that will compare the efficacy of a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. The study interventions will be delivered in a group format and provided remotely using a secure telehealth services platform. The study assessments will be completed using a secure telehealth services platform and online electronic data capture systems. An independent evaluator (IE) masked to treatment condition will administer all assessments during the treatment and follow-up periods.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Bowdoin College, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Joseph F McGuire, PhD, Principal investigator, Johns Hopkins UniversityHannah Reese, PhD, Principal investigator, Bowdoin College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408662
- Sponsor's protocol ID
- IRB00413599
- Other IDs
- R01AT012455
- Acronym
- MBIT
- Status last verified
- May 2026
- First submitted
- 6 May 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Delivery of a Mindfulness-based Intervention for Tics
- ClinicalTrials.gov ID
- NCT06408662
- Acronym / sponsor ID
- MBIT / IRB00413599
- Conditions
- Tourette Syndrome, Tourette's Disorder, Chronic Motor Tic Disorder, Chronic Vocal Tic Disorder, Persistent Motor Tic Disorder, Persistent Vocal Tic Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Bowdoin College, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 23 May 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to compare a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) for individuals with Tourette's syndrome or Persistent Tic Disorders (collectively TS). It is the investigator's hope that this information cam be used to improve current treatments for individuals with TS.
Detailed description
Tourette's syndrome and other persistent tic disorders (collectively, TS) is a condition that onsets in childhood and affects ~1% of the population. Alongside motor and vocal tics, patients with TS experience distressing somatosensory sensations (i.e., premonitory urges) and co-occurring mental health conditions such as anxiety disorders, depressive disorders, obsessive-compulsive disorder (OCD), and ADHD. Tics and comorbid symptoms cause individuals with TS significant distress and impairment across life domains (e.g., physical, social, academic, occupational, emotional, and familial). Two evidence-based treatments exist for TS: behavior therapy and pharmacotherapy. Behavior therapy [often referred to as habit reversal training (HRT) or the comprehensive behavioral intervention for tics (CBIT)] is an evidence-based treatment that has been shown to reduce the severity of tic symptoms, and has a low risk for adverse effects. Although behavior therapy is recognized as a first-line intervention for TS, less than 40% of adults with TS respond to this evidence-based treatment. Additionally, current behavioral interventions are often inaccessible for adults with TS. While pharmacotherapy for tic management (e.g., antipsychotic medications) has been shown to be effective, these treatments can have adverse side effects with detrimental health consequences. Thus, there is a critical need for new treatments for adults with TS that are efficacious for reducing tic severity, beneficial for co-occurring conditions, and have few adverse health effects. Mindfulness-based interventions have proven beneficial for adults with a wide range of neuropsychiatric conditions. Based on the investigator's prior work, the investigators believe that a mindfulness-based intervention for tics (MBIT) is beneficial for adults with TS.
This project is a randomized controlled trial (RCT) that will compare the efficacy of a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth services platforms and online electronic data capture systems. An independent evaluator (IE) masked to treatment condition will administer all assessments during the treatment and follow-up periods. The investigators will test the mechanisms by which MBIT reduces tic severity, and examine the efficacy of MBIT relative to PRST for common co-occurring psychiatric symptoms and quality of life impairments-towards "treating the whole person". Finally, the investigators will explore the sustained therapeutic improvement from MBIT over a 6-month follow-up period focusing on tic severity, tic-related impairment, co-occurring psychiatric symptoms, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This project is a randomized controlled trial (RCT) that will compare the efficacy of a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. The study interventions will be delivered in a group format and provided remotely using a secure telehealth services platform. The study assessments will be completed using a secure telehealth services platform and online electronic data capture systems. An independent evaluator (IE) masked to treatment condition will administer all assessments during the treatment and follow-up periods.
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based intervention for tics (MBIT) | Experimental | Other: mindfulness-based intervention for tics (MBIT)This is an 8-week mindfulness-based group intervention delivered via telehealth. It consists of mindfulness and meditative practice, didactics, inquiry, discussion and weekly therapeutic exercises and assignments (i.e., homework). |
| psychoeducation with relaxation and supportive therapy (PRST) | Active comparator | Other: psychoeducation with relaxation and supportive therapy (PRST)This is an 8-week educational and supportive therapy group intervention delivered via telehealth. It consists of psychoeducation, relaxation, discussion, and weekly therapeutic exercises and assignments (i.e., homework). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be ≥18 years of age;
- meet diagnostic criteria for a primary or co-primary diagnosis of Tourette Syndrome or a Persistent Motor or Vocal Tic Disorder on a structured clinical interview;
- have moderate or greater tic severity as evidenced by a YGTSS Total Tic Score of >14 (when motor and vocal tics are present) or >10 (when only motor or vocal tics are present);
- be medication free and/or on a stable dose of psychiatric medication 8 weeks prior to study participation;
- be not engaged in psychotherapy for non-TS conditions and/or be on a stable course of therapy for 6 months prior to study participation
Key exclusion criteria (4 listed)
- a current diagnosis of substance use disorder, psychosis, mania or another condition that requires another form of care;
- severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention;
- concurrent psychotherapy for TS;
- prior extensive experience with mindfulness and/or meditation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness-based intervention for tics (MBIT)Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practice | Other | mindfulness-based intervention for tics (MBIT) |
| psychoeducation with relaxation and supportive therapy (PRST)Psychological Intervention that focuses on learning more about tics, practicing a range of strategies for coping with tics (e.g., relaxation, effective communication), and discussing challenges commonly experienced by individuals with tics. | Other | psychoeducation with relaxation and supportive therapy (PRST) |
Primary outcome
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
Time frame: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
The YGTSS is a clinician-administered measure of tic symptom severity (0-50) and impairment (0-50). Greater scores are reflective of greater severity and/or impairment.
11 secondary outcomes
Clinical Global Impressions Scales of Severity and Improvement (CGI-S & CGI-I)
Time frame: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Adult Tic Questionnaire (ATQ)
Time frame: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Yale-Brown Obsessive Compulsive Scale-II
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Attention-Deficit Hyperactivity Rating Scale (ADHD-RS)
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Premonitory Urge to Tic Scale (PUTS)
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Client Satisfaction Questionnaire
Time frame: Post-treatment (Week 9)
Self Compassion Scale
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Affective Reactivity Index
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Brief Irritability Test
Time frame: Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph F McGuire, PhD principal investigator
Johns Hopkins University
Hannah Reese, PhD principal investigator
Bowdoin College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness-based intervention for tics (MBIT) and psychoeducation with relaxation and supportive therapy (PRST) in people with Tourette Syndrome and Tourette's Disorder, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Browning (443-300-8836, mbit@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (time frame: Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.