RecruitingNot ApplicableNCT05931913

TMS + Exposure Therapy for Pediatric OCD

Transcranial Magnetic Stimulation to Augment Exposure and Response Prevention for Pediatric OCD


Sponsor

Bradley Hospital

Enrollment

60 participants

Start Date

Mar 20, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 12 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining transcranial magnetic stimulation (TMS — a non-invasive brain stimulation technique) with exposure-based therapy (a type of cognitive-behavioral therapy) is more effective than exposure therapy alone for treating OCD in young people. **You may be eligible if...** - You are between 12 and 21 years old - You have OCD with moderate or greater symptoms confirmed by a clinical scale - Your OCD includes physical (motor) compulsions - You are fluent in English **You may NOT be eligible if...** - You have a personal or immediate family history of epilepsy, bipolar disorder, intracranial abnormalities, brain tumors, stroke, or metal implants in the head - You have a pacemaker or significant heart disease - You are pregnant or not using effective contraception (if applicable) - You cannot have an MRI - You are left-handed - You are at imminent risk of suicide - You are currently receiving another form of psychotherapy for OCD - You have received TMS treatment in the past 3 months - You are taking medications that significantly increase seizure risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex

TMS will be delivered over the dorsolateral prefrontal cortex (dlPFC) using an intermittent bursting pattern

BEHAVIORALExposure with Response Prevention

ERP will be delivered daily, immediately following TMS

DEVICETranscranial 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

DEVICETranscranial 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


Locations(2)

University of Minnesota

Minneapolis, Minnesota, United States

Emma Pendleton Bradley Hospital

Riverside, Rhode Island, United States

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NCT05931913


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