TMS + Exposure Therapy for Pediatric OCD

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Bradley Hospital
Study ID
NCT05931913
Status
Recruiting
Apply to this trial

Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
12 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex — DEVICE
    TMS will be delivered over the dorsolateral prefrontal cortex (dlPFC) using an intermittent bursting pattern
  • Exposure with Response Prevention — BEHAVIORAL
    ERP will be delivered daily, immediately following TMS
  • Transcranial Magnetic Stimulation: Sham — DEVICE
    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
  • Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area — DEVICE
    TMS will be delivered over the pre supplementary motor area (preSMA) using a continuous bursting pattern

Study Details

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)

Key Dates

First listed
Jul 5, 2023
Start date
Mar 20, 2024
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ERP+iTBS
    Participants will receive two weeks (10 sessions) of intermittent theta burst stimulation (iTBS; a form of TMS) targeting the dorsolateral prefrontal cortex (dlPFC), followed immediately by Exposure Plus Response Prevention (ERP).
  • Experimental: ERP+cTBS
    Participants will receive two weeks (10 sessions) of continuous theta burst stimulation (cTBS; a form of TMS) targeting the presupplementary motor area (pSMA), followed immediately by Exposure Plus Response Prevention (ERP).
  • Active Comparator: ERP+Sham
    Participants will receive two weeks (10 sessions) of sham ("fake") TMS, followed immediately by Exposure Plus Response Prevention (ERP).

Primary Outcome Measure

Functional Magnetic Resonance Imaging (fMRI): connectivity of the pSMA-DLS circuit [ Time Frame: change from baseline at two weeks (post-treatment) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55414
Christine Conelea, PhD
[email protected]
612-261-3127
Emma Pendleton Bradley HospitalRiversideRhode Island02915
Kristen Benito, PhD
[email protected]
401-432-1473

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By research site
University of Minnesota· Minneapolis, MNEmma Pendleton Bradley Hospital· Riverside, RI

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