TMS for Improving Response Inhibition in Adolescents With OCD

Study Overview
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Brief Summary
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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.

Official Title
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TMS for Improving Response Inhibition in Adolescents With OCD

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 13-18 years Presence of OCD, as indicated by score on the Children's Yale-Brown Obsessive-Compulsive Scale Patient and one parent speak English fluently (to ensure comprehension of study measures and instructions Right-handed If taking psychotropic medications, these have been stable for > 6 weeks and are expected to remain stable for the approximately 3-week study protocol If currently in psychotherapy, symptom improvement has plateaued (no improvement in the past 6 weeks and symptoms expected to remain stable for the approximately 3-week study protocol) 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) Metal in the head, except mouth (e.g., cochlear implant, implanted brain stimulators, aneurysm clips) Active suicidality or psychosis Existing diagnosis of Bipolar disorder, Autism Spectrum Disorder, mental retardation, or cognitive disability Substance abuse or dependence Taking a stimulant medication (and unwilling to forgo on study visit days) Taking medication with the potential to lower seizure threshold (e.g., neuroleptics, antipsychotics) Patient is a ward of the state Family history of epilepsy History of syncope

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TMS at visit 1, Sham at visit 2<br>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<br>* All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)<br>|
| Other: Sham at visit 1, TMS at visit 2<br>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<br>* All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in response time on stop trials of the stop signal task | Computerized task, where shorter response time (in seconds) indicates better performance | Change from pre (within 1 hour before) to post (within 1 hour after) intervention | 
| Change in frontocentral P3 amplitude on Electroencephalogram (EEG) | Electroencephalogram (EEG) | Change from pre (within 1 hour before) to post (within 1 hour after) intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-item self-report symptom questionnaire | self-rated mood and OCD symptoms on a 0-5 scale, where higher scores indicate more symptoms | post (within 1 hour after) intervention |