An interventional study of Comprehensive Behavioral Intervention for Tics (CBIT) and Repetitive Transcranial Magnetic Stimulation (rTMS) in Tic Disorders, Tics and Tic, Motor, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
The study will examine whether combining Comprehensive Behavioral Intervention for Tics (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression ability, and enhances CBIT outcomes in young people with tic disorder. The study will also examine different TMS dosing strategies.
All participants will receive 10 daily sessions of CBIT, a well-established behavioral treatment that is considered by the American Academy of Neurology to be the first-line intervention for tics. Immediately prior to each CBIT session, participants will undergo TMS targeting the SMA. The specific type of TMS procedure will be randomly assigned between subjects and be either: 1 Hz repetitive TMS (rTMS), continuous theta burst stimulation (cTBS), or sham stimulation.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's enrollment of 50 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
Compared within Tourette Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tic Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with 1 Hz repetitive Transcranial Magnetic Stimulation (rTMS).
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT) · Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with continuous Theta Burst Stimulation (cTBS).
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT) · Device: Continuous Theta Burst Stimulation (cTBS)
Participants in this arm will receive Comprehensive Behavioral Intervention for Tics (CBIT) with either a cTBS or rTMS sham treatment.
Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
CBIT is a manualized treatment program focused on tic management skills
During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region
During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region
Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits
For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
Time frame: baseline to post-treatment; approximately 10 days
Change in SMA Activation
For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
Time frame: baseline to post-treatment; approximately 10 days
Safety: Measured as Rate of Adverse Events Related to Study Treatment
The number of adverse events judged to be treatment related will be totaled and reported for each group.
Time frame: approximately 3-4 months
Change in Tic Suppression Task
The Tic Suppression Task is a clinician-rated tool for assessing tic frequency. A video recording of participant is rated and yields a score in units of tics per minute. Outcome reported as change from baseline to post treatment; change from baseline to 1 month post treatment; change from baseline to 3 months post treatment; change from post treatment to 1 month post treatment; and change from post treatment to 3 months post treatment.
Time frame: baseline to 3 months post-treatment
Feasibility: Measured as Participant Treatment Completion
For each group, the number of participants who completed at least 80% of treatment sessions will be totaled and reported for each group.
Time frame: approximately 3-4 months
| Milestone | Active Comparator: 1 Hz rTMS | Active Comparator: cTBS | Sham Comparator: Sham |
|---|---|---|---|
| Started | 17 | 16 | 17 |
| Completed | 17 | 15 | 16 |
| Not completed | 0 | 1 | 1 |
For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
| eta squared | CBIT + rTMS | CBIT + cTBS | CBIT + Sham |
|---|---|---|---|
| Change in Resting State fMRI Connectivity of SMA-mediated Brain Circuits | 0.0312 ± 0.05 | 0.261 ± 0.05 | 0.158 ± 0.03 |
For each participant, signal intensity (unitless measure) will be measured using fMRI in the supplementary motor area (SMA) during a finger tapping task. An ANOVA will be conducted to compare change in signal intensity within SMA from pre- to post-treatment across the groups. The outcome will be reported as an effect size value (Cohen's d).
| eta squared | CBIT + rTMS | CBIT + cTBS | CBIT + Sham |
|---|---|---|---|
| Change in SMA Activation | 0.45 ± 1.25 | 0.01 ± 1.25 | 0.27 ± 1.3 |
The number of adverse events judged to be treatment related will be totaled and reported for each group.
| events | CBIT + rTMS | CBIT + cTBS | CBIT + Sham |
|---|---|---|---|
| Safety: Measured as Rate of Adverse Events Related to Study Treatment | 46 | 22 | 18 |
The Tic Suppression Task is a clinician-rated tool for assessing tic frequency. A video recording of participant is rated and yields a score in units of tics per minute. Outcome reported as change from baseline to post treatment; change from baseline to 1 month post treatment; change from baseline to 3 months post treatment; change from post treatment to 1 month post treatment; and change from post treatment to 3 months post treatment.
| tics per minute | CBIT + rTMS | CBIT + cTBS | CBIT + Sham |
|---|---|---|---|
| Change in Tic Suppression Task | 0.58 ± 9.47 | -3.83 ± 23.92 | -8.24 ± 15.71 |
For each group, the number of participants who completed at least 80% of treatment sessions will be totaled and reported for each group.
| participants | CBIT + rTMS | CBIT + cTBS | CBIT + Sham |
|---|---|---|---|
| Feasibility: Measured as Participant Treatment Completion | 17 | 15 | 16 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Comparator: 1 Hz rTMS | 0/17 (0%) | 0/17 (0%) | 17/17 (100%) |
| Active Comparator: cTBS | 0/15 (0%) | 0/15 (0%) | 15/15 (100%) |
| Sham Comparator: Sham | 0/16 (0%) | 0/16 (0%) | 14/16 (87.5%) |
| Event | Active Comparator: 1 Hz rTMS | Active Comparator: cTBS | Sham Comparator: Sham |
|---|---|---|---|
| HeadacheGeneral disorders | 7/17 | 6/15 | 7/16 |
| Muscle TwitchMusculoskeletal and connective tissue disorders | 7/17 | 0/15 | 2/16 |
| sleep disturbanceGeneral disorders | 4/17 | 3/15 | 1/16 |
| OtherGeneral disorders | 2/17 | 1/15 | 2/16 |
| PainGeneral disorders | 1/17 | 1/15 | 2/16 |
| Mood changeGeneral disorders | 2/17 | 1/15 | 0/16 |
| Scalp discomfortSkin and subcutaneous tissue disorders | 2/17 | 0/15 | 0/16 |
| NauseaGeneral disorders | 1/17 | 1/15 | 0/16 |
| Concentration difficultiesGeneral disorders | 1/17 | 1/15 | 0/16 |
| Hearing difficultiesGeneral disorders | 0/17 | 1/15 | 0/16 |
| Age, Categorical(Participants) | Active Comparator: 1 Hz rTMS | Active Comparator: cTBS | Sham Comparator: Sham | Total |
|---|---|---|---|---|
| <=18 years | 13 | 12 | 12 | 37 |
| Between 18 and 65 years | 4 | 4 | 5 | 13 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Active Comparator: 1 Hz rTMS | Active Comparator: cTBS | Sham Comparator: Sham | Total |
|---|---|---|---|---|
| Female | 8 | 8 | 7 | 23 |
| Male | 9 | 8 | 10 | 27 |
| Race (NIH/OMB)(Participants) | Active Comparator: 1 Hz rTMS | Active Comparator: cTBS | Sham Comparator: Sham | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 13 | 14 | 15 | 42 |
| More than one race | 2 | 2 | 2 | 6 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Some datasets (to be determined) will be made available via NIH National Database Archive.
Ran from Nov 2020 to primary completion in Dec 2023, 37 months.
Results were first posted in Mar 2025, 1 year 2 months after primary completion.
Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's 37 months is above that.
Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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