Recruiting

TMS

Sponsor:

UCLA

Code:

NCT07065669

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Dorsal medial Prefrontal Cortex intermittent theta burst stimulation

cTBS to ROFC

Study Details

Brief summary:

This is a pilot study to examine the tolerability, safety and early efficacy of two forms of transcranial magnetic stimulation (TMS) for treating adolescents with Obsessive Compulsive Disorder (OCD) who have experienced limited improvements with usual treatments for OCD in adolescents.

The project's primary goal is to examine whether adolescents can complete 3 consecutive weeks of TMS administered 5 days per week, and to describe the type of and how common individual side effects with TMS occur in adolescents with OCD.

Participants will:

  • visit the clinic every weekday for 3 weeks (15 days) to receive TMS treatments
  • have a brain MRI scan before TMS treatments begins and after finishing all TMS
  • complete questionnaires and report changes in behavior and physical symptoms

Conditions

Obsessive-Compulsive Disorder

Study ID

NCT07065669

Start date

Jun 1, 2025

Status verified date

Sep, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. outpatients
2. ages 13 - 17 years
3. meets current DSM-5 criteria for Obsessive Compulsive Disorder with screening CY-BOCS II score > 16 (moderate to severe).
4. stable on chronic psychotropic medications and/or therapy for 8 weeks prior to the study and agreeable to continue throughout the study without changes.
5. participants may continue to take medications and record daily usage throughout the study.
6. capacity to provide informed assent and parent or legal guardian able to provide consent.
7. ability to tolerate clinical study procedures.
8. successfully complete the screening forms without any contraindications.

Exclusion Criteria:

1. Psychiatric: history of schizophrenia, bipolar disorder, substance/alcohol abuse disorder, current elevated suicide risk, prior psychosurgery, prior ECT.
2. Neurologic: severe neurocognitive disorder, seizure disorder, certain structural brain lesions (e.g., intracranial mass lesions, hydrocephalus, sequelae of meningitis, frank brain injury).
3. TMS contraindications: implanted device; presence of metal in the head, including eyes and ears (excluding dental implants); certain tics; medications or systemic illness that predispose seizure risk; family history of 1st degree relative with seizure disorder.
4. Subjects with an unstable physical, systemic, or metabolic disorder (e.g., unstable hypertension, malnutrition secondary to eating disorder).
5. Females who are pregnant or nursing (as determined by a questionnaire and pregnancy test).
6. Current and anticipated continued treatment with excluded medication (See prohibited list).
7. Inability to complete the research protocol as determined by the Principal Investigator.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Right Orbitofrontal TBS

continuous theta burst stimulation

active comparator: TBS of dorsal, medial prefrontal cortex

intermittent theta burst stimulation (iTBS) will be delivered to the dmPFC

Interventions

Dorsal medial Prefrontal Cortex intermittent theta burst stimulation

iTBS stimulation of the dmPFC is a FDA-approved treatment for adults with OCD

cTBS to ROFC

continuous theta burst stimulation (cTBS) 1,800 pulses per session

Primary outcome measure

  • Completion rate [ Time Frame: Baseline to completion of all protocol visits, up to 8 weeks ]
  • Adverse events [ Time Frame: Baseline to completion of all protocol visits up to 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94107

Contacts

Principal Investigator:

James T McCracken, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Adolescent
  • transcranial magnetic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-09-08.