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RECRUITING

NCT07859683

TMS + Exposure Therapy for Pediatric OCD: Second Phase

Sponsor: Bradley Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to test 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 two groups: ERP with active ("real") TMS vs. ERP with sham ("fake") TMS. The first phase of this study found that active TMS+ERP normalized functioning in brain circuits that contribute to compulsive behavior. This second phase will test whether TMS-induced brain changes lead to improvements in OCD symptom severity. 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)

Official title: Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD

Key Details

Gender

All

Age Range

12 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-31

Completion Date

2029-10-31

Last Updated

2026-10-19

Healthy Volunteers

Conditions

Obsessive Compulsive Behavior

Interventions

DEVICE

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

DEVICE

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

BEHAVIORAL

Exposure with Response Prevention

ERP will be delivered daily, immediately following TMS

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. * 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)

Locations (2)

University of Minnesota

Minneapolis, Minnesota, United States

Emma Pendleton Bradley Hospital

Providence, Rhode Island, United States