An interventional study of Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder, sponsored by Bradley Hospital. Completed at 1 site in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Bradley Hospital · Not applicable, Interventional, and Treatment
The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits, improves response inhibition, and reduces compulsions in adolescents with OCD.
626 studies on the registry are indexed under Obsessive-Compulsive Disorder; 162 are open to participants now.
This study's enrollment of 7 is below the median of 45 across 510 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Bradley Hospital is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
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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:
Medical conditions contraindicated for TMS or EEG, including history of intracranial pathology, increased intracranial pressure, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, possible pregnancy (female of childbearing age not using effective contraception), or any other serious medical condition (note that medical history will be reviewed by a study physician prior to TMS administration)
At visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location.
Device: Transcranial Magnetic Stimulation
At visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location.
Device: Transcranial Magnetic Stimulation
All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)
Change in Response Time on Stop Trials of the Stop Signal Task
Computerized task, where shorter response time (in milliseconds) indicates better performance
Time frame: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG)
Electroencephalogram (EEG) measured amplitude on successful stop trials of the stop signal task (SST). Calculated by averaging the epochs of successful stop trials time-locked to the stop signal from the midline electrode (Cz).
Time frame: Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Self-report Symptom Question
Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions
Time frame: post (within 1 hour after) intervention
Participants were recruited from a pediatric OCD specialty clinic between March 2022 and March 2023. Note that recruitment began in March 2022 before the first participant was formally enrolled on the study start date of April 1, 2022.
| Milestone | TMS at Visit 1, Sham at Visit 2 | Sham at Visit 1, TMS at Visit 2 |
|---|---|---|
| Started | 3 | 4 |
| Completed | 3 | 3 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Computerized task, where shorter response time (in milliseconds) indicates better performance
| milliseconds | Active TMS | Sham (Fake) TMS |
|---|---|---|
| Change in Response Time on Stop Trials of the Stop Signal Task | -26.2 ± 102.1 | -31.7 ± 123.1 |
Electroencephalogram (EEG) measured amplitude on successful stop trials of the stop signal task (SST). Calculated by averaging the epochs of successful stop trials time-locked to the stop signal from the midline electrode (Cz).
| microvolts (µV) | Active TMS | Sham (Fake) TMS |
|---|---|---|
| Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG) | 0.5 ± 2.9 | 1.5 ± 2.2 |
Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions
| units on a scale | Active TMS | Sham (Fake) TMS |
|---|---|---|
| Self-report Symptom Question | 2.7 ± 1.4 | 2.5 ± 2.1 |
Collected over Data were collected at one of two study visits that occurred over the course of two weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active TMS | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Sham (Fake) TMS | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Event | Active TMS | Sham (Fake) TMS |
|---|---|---|
| HeadacheNervous system disorders | 0/6 | 1/6 |
| Scalp discomfortNervous system disorders | 1/6 | 0/6 |
Not different from information reported in participant flow
| Age, Categorical(Participants) | TMS at Visit 1, Sham at Visit 2 | Sham at Visit 1, TMS at Visit 2 | Total |
|---|---|---|---|
| <=18 years | 3 | 4 | 7 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | TMS at Visit 1, Sham at Visit 2 | Sham at Visit 1, TMS at Visit 2 | Total |
|---|---|---|---|
| Mean | 13.7 ± 1.2 | 16.3 ± 1.0 | 15.1 ± 1.7 |
| Sex/Gender, Customized(Participants) | TMS at Visit 1, Sham at Visit 2 | Sham at Visit 1, TMS at Visit 2 | Total |
|---|---|---|---|
| Male | 1 | 0 | 1 |
| Female | 2 | 3 | 5 |
| Nonbinary | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | TMS at Visit 1, Sham at Visit 2 | Sham at Visit 1, TMS at Visit 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 3 | 4 | 7 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | TMS at Visit 1, Sham at Visit 2 | Sham at Visit 1, TMS at Visit 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 3 | 4 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | TMS at Visit 1, Sham at Visit 2 | Sham at Visit 1, TMS at Visit 2 | Total |
|---|---|---|---|
| United States | 3 | 4 | 7 |
| Children's Yale Brown Obsessive Compulsive Scale (CYBOCS)(units on a scale) | TMS at Visit 1, Sham at Visit 2 | Sham at Visit 1, TMS at Visit 2 | Total |
|---|---|---|---|
| Mean | 24.0 ± 1.7 | 24.3 ± 5.3 | 24.1 ± 3.8 |
Documents are hosted by the registry — open the source record to download them.
Ran from Apr 2022 to primary completion in Aug 2023, 16 months.
Results were first posted in Jan 2025, 1 year 5 months after primary completion.
Of 230 non-industry interventional studies with no phase under Obsessive-Compulsive Disorder, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 68. This study's 16 months is below that.
Counting every sponsor, half of 232 studies reached it within 43 months; a quarter within 22 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Obsessive-Compulsive Disorder →
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