TMS + Exposure Therapy for Pediatric OCD

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

Interventions

DEVICE

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

BEHAVIORAL

Exposure with Response Prevention

ERP will be delivered daily, immediately following TMS

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

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

Sponsors & Collaborators

• University of Minnesota

  collaborator OTHER

• Butler Hospital

  collaborator OTHER

• Bradley Hospital

  lead OTHER

Principal Investigators

• Kristen Benito, PhD · Emma Pendleton Bradley Hospital

• Christine Conelea, PhD · University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-20

Primary Completion

2026-06-30

Completion

2026-07-31

FDA Device

Yes

Countries

• United States

Study Locations