NCT07859683 TMS + Exposure Therapy for Pediatric OCD: Second Phase
| NCT ID | NCT07859683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bradley Hospital |
| Condition | Obsessive Compulsive Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-10-31 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-10-31 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
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)
Contact & Investigator
Kristen Benito, PhD
PRINCIPAL INVESTIGATOR
Emma Pendleton Bradley Hospital
Frequently Asked Questions
Who can join the NCT07859683 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 21 Years, studying Obsessive Compulsive Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07859683 currently recruiting?
Yes, NCT07859683 is actively recruiting participants. Contact the research team at kbenito@brownhealth.org for enrollment information.
Where is the NCT07859683 trial being conducted?
This trial is being conducted at Minneapolis, United States, Providence, United States.
Who is sponsoring the NCT07859683 clinical trial?
NCT07859683 is sponsored by Bradley Hospital. The principal investigator is Kristen Benito, PhD at Emma Pendleton Bradley Hospital. The trial plans to enroll 60 participants.