Recruiting

TMS & Exposure Therapy

Sponsor:

Bradley Hospital

Code:

NCT05931913

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex

Exposure with Response Prevention

Transcranial Magnetic Stimulation: Sham

Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area

Study Details

Brief summary:

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:

  • Complete clinical interviews, questionnaires, and computerized tasks
  • Complete two MRIs (brain scans)
  • Receive daily TMS followed by ERP for two weeks (10 sessions)

Conditions

Obsessive-Compulsive Disorder

Study ID

NCT05931913

Start date

Mar 20, 2024

Status verified date

Aug, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between the ages of 12 and 21 years.
  • Presence of OCD, as indicated by a score of > 16 on the Children's Yale-Brown Obsessive Compulsive Scale, indicating moderate or greater OCD symptoms.
  • Presence of motor compulsions on CY-BOCS compulsion checklist
  • English fluency to ensure comprehension of informed consent and study measures and instructions.

Exclusion Criteria:

  • Decline to provide informed consent.
  • Has a personal history, or a family history in a first-born relative, of any medical or psychiatric disorder, disease, condition, injury, symptoms or circumstance that, in the opinion of the principal investigator, may: (1) impact the risk profile of TMS; (2) reduce the subject's ability to fulfill the study requirements as per protocol; or (3) adversely impact the integrity of the data or the validity of the study results." Some examples include: epilepsy or seizure disorder(s), bipolar disorder or any psychiatric disorder associated with a risk of mania, intracranial pathology, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, or moderate-severe heart disease
  • Pregnant according to the medical history or a urine pregnancy test; and menstruating females who are heterosexually active and not using a highly effective form of contraception (tubal ligation, FDA-approved hormonal contraceptive, or an IUD)
  • Inability to undergo MRI.
  • Left handedness.
  • Is deemed to be at imminent risk of suicide according to the Ask Suicide-Screening Questions (ASQ) (i.e. answers YES to ≥ one (1) of the four screening questions) and/or in the medical opinion of the investigator
  • History of, or risk factors for, neurocardiogenic syncope (history of syncope/ presyncope related to noxious stimuli, anxiety, micturation, or posture).
  • Concurrent psychotherapy of any kind for OCD.
  • Concurrent TMS or receipt of any TMS experimental or clinical treatment less than 3 months prior to enrollment.
  • Taking a medication deemed to pose high seizurogenic potential per physician review
  • Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the study period)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ERP+iTBS

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).

experimental: ERP+cTBS

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).

active comparator: ERP+Sham

Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).

Interventions

Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex

TMS will be delivered over the dorsolateral prefrontal cortex (dlPFC) using an intermittent bursting pattern

Exposure with Response Prevention

ERP will be delivered daily, immediately following TMS

Transcranial Magnetic Stimulation: Sham

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

Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area

TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern

Primary outcome measure

  • Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit [ Time Frame: change from baseline at two weeks (post-treatment) ]
  • Functional Magnetic Resonance Imaging (fMRI): connectivity of the dlPFC-DMS circuit [ Time Frame: change from baseline at two weeks ]
  • Observed Compulsive Behavior [ Time Frame: two weeks ]

Central Contacts and Locations

Central contacts

Kristen Benito, PhD

410-432-1054kbenito@lifespan.org

Christine Conelea, PhD

cconelea@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Christine Conelea, PhD

612-261-3127cconelea@umn.edu

Emma Pendleton Bradley Hospital

Recruiting

Riverside, Rhode Island, United States, 02915

Contacts

Kristen Benito, PhD

401-432-1473kbenito@lifespan.org

More Information

Sponsor

Bradley Hospital

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Bradley Hospital on 2026-08-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.