Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation

Study Overview
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Brief Summary
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The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain stimulation might change the functioning of regions implicated in OCD, and thereby inform possible future therapeutic uses.

Official Title
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Neurocircuitry of OCD: Effects Of Modulation

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: Transcranial Magentic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current primary OCD diagnosis and current Y-BOCS total score of ≥16 18-70 years of age Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry Ongoing psychotherapy allowed if already established for three months or more before study entry Exclusion Criteria: History of primary psychotic disorder or bipolar disorder Present acute suicidality History of head injury, epilepsy, or other clinically significant neurological illness except tic disorders Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease Premorbid intelligence quotient (IQ) estimate < 80 Visual disturbance (<20/40 Snellen visual acuity, corrected) Current, or alcohol or illicit substance abuse/dependence in the last 3 months Contraindications to TMS or MRI: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia Women who are pregnant or breastfeeding. All women participants of reproductive age are required to have a negative pregnancy test prior to enrollment and use medically acceptable birth control throughout the study (barrier and/or oral contraceptives) Current psychotic symptoms An increased risk of seizure, determined by history Medications judged to notably affect cortical excitability e.g., anticonvulsants or high-dose benzodiazepines (> 4 mg/day of clonazepam or equivalent) Predominant hoarding symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Magnetic Stimulation<br>Transcranial Magnetic Stimulation applied over the pre-supplementary motor area (pSMA), for ten sessions, Monday through Friday, over the course of two weeks. | Device: Transcranial Magentic Stimulation<br>* This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks<br>* Other names: Continuous Theta Burst Stimulation (cTBS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT) |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |  | Baseline and 6 months |