TMS plus ERP for pediatric OCD: Phase 2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized phase, youth aged 12–21 with OCD receive daily transcranial magnetic stimulation (real or sham) followed by exposure with response prevention over two weeks, alongside MRI scans and assessments. The goal is to see if TMS changes brain circuits related to compulsive behavior and improves OCD symptoms when combined with ERP. The study uses a masked design to compare active versus sham TMS in addition to ERP, with 30 participants per group. Recruitment centers include the University of Minnesota and Bradley Hospital, with multiple sites involved in the collaboration.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• Emma Pendleton Bradley Hospital
  Providence, Rhode Island, United States Recruiting

Study contacts

• Principal investigator: Kristen Benito, PhD — Emma Pendleton Bradley Hospital
• Study coordinator: Kristen Benito, PhD
• Email: kbenito@brownhealth.org
• Phone: 4014321054

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.