An interventional study of Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex and Exposure with Response Prevention in Obsessive-Compulsive Disorder, sponsored by Bradley Hospital. Recruiting at 2 sites in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Bradley Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare different forms of transcranial magnetic stimulation (TMS) for improving the outcomes of Exposure with Response Prevention (ERP) in youth and young adults with Obsessive-Compulsive Disorder (OCD). Researchers will compare three groups: ERP with one of two different active ("real") forms of TMS vs. ERP with sham ("fake") TMS. The main questions this study aims to answer are: 1) whether TMS normalizes functioning in brain circuits that contribute to compulsive behavior, and 2) whether TMS reduces compulsions during ERP. Participants will:
Pediatric OCD is a public health problem and many remain symptomatic even after receiving efficacious treatments. The success of exposure and response prevention (ERP), a first-line behavioral treatment, depends on the ability to refrain from compulsions during exposure tasks. Improving this "therapy critical behavior" is a potentially important strategy for ERP augmentation. Repetitive transcranial magnetic stimulation (rTMS) can be leveraged to stimulate healthier functioning of brain circuits underlying therapy critical behaviors. The overall objective of this project is to test whether augmenting ERP with rTMS over cortical nodes of select cortico-striatal circuits implicated in compulsivity can normalize connectivity and enhance response prevention in youth and young adults with OCD. This project will use a masked RCT design to test whether ERP+TMS engages 1) hypothesized circuits involved in compulsivity and 2) observed response prevention during ERP exposure tasks. Youth ages 12-21 years with OCD will complete a full course of ERP plus randomly assigned TMS regimens of sham, inhibitory theta burst stimulation (iTBS) to the dorsolateral prefrontal cortext (dlPFC), or continuous theta burst stimulation (cTBS) to the presupplementary motor area (pSMA; n=20 per group). Milestones for the R61 phase are determination that at least one active rTMS condition a) changes resting state functional connectivity in the hypothesized circuit within- and between-subjects and b) is safe and feasible.
606 studies on the registry are indexed under Obsessive-Compulsive Disorder; 160 are open to participants now.
This study's planned enrollment of 60 is above the median of 45 across 492 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Bradley Hospital is the lead sponsor of 21 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive two weeks (10 sessions) of intermittent theta burst stimulation (iTBS; a form of TMS) targeting the dorsolateral prefrontal cortex (dlPFC), followed immediately by Exposure Plus Response Prevention (ERP).
Device: Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex · Behavioral: Exposure with Response Prevention
Participants will receive two weeks (10 sessions) of continuous theta burst stimulation (cTBS; a form of TMS) targeting the presupplementary motor area (pSMA), followed immediately by Exposure Plus Response Prevention (ERP).
Behavioral: Exposure with Response Prevention · Device: Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area
Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).
Behavioral: Exposure with Response Prevention · Device: Transcranial Magnetic Stimulation: Sham
TMS will be delivered over the dorsolateral prefrontal cortex (dlPFC) using an intermittent bursting pattern
Also known as: TMS, Neuromodulation, iTBS
ERP will be delivered daily, immediately following TMS
Also known as: ERP, Exposure Therapy, Cognitive-Behavioral Therapy, CBT
Sham stimulation will use the Magstim sham air-cooled coil, which produces auditory signals and appears identical to an active coil but contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (\<3%) magnetic field is delivered to the cortex
Also known as: TMS, Neuromodulation
TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern
Also known as: TMS, iTBS, Neuromodulation
Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit
z-score representing change in resting state connectivity between presupplementary motor area (pSMA) and dorsolateral striatum (DLS)
Time frame: change from baseline at two weeks (post-treatment)
Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit
z-score representing change in resting connectivity between dorsolateral prefrontal cortex and dorsomedial striatum (DMS)
Time frame: change from baseline at two weeks
Observed Compulsive Behavior
Mean proportion of time during which compulsions are observed during ERP sessions
Time frame: two weeks
Child/Adult Yale-Brown Obsessive Compulsive Inventory
Independent-Evaluator (IE) rated measure of OCD symptom severity. Rated on 0 (no symptoms) to 40 (most extreme symptoms) scale
Time frame: change from baseline at two weeks (post-treatment)
Plan to share: Yes — We will share all de-identifiable data from study measures through the National Institute of Mental Health (NIMH) Data Archive (NDA) using the data dictionaries available in NDA. As per NIMH Data Archive, data will be deidentified and assigned a Global Unique Identifier (GUID). We will also share deidentified study data via the National Database for Clinical Trials (NDCT) related to Mental Illness.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Obsessive-Compulsive Disorder→
Bradley Hospital