TMS + Exposure Therapy for Pediatric OCD

Last updated: July 1, 2024
Sponsor: Bradley Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obsessive-compulsive Disorder

Anxiety Disorders

Kleptomania

Treatment

Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex

Transcranial Magnetic Stimulation: continuous theta burst to pre supplementary motor area

Exposure with Response Prevention

Clinical Study ID

NCT05931913
00072077
  • Ages 12-21
  • All Genders

Study 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 Criteria

Inclusion

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-BrownObsessive 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 andinstructions.

Exclusion

Exclusion Criteria:

  • Decline to provide informed consent.

  • Has a personal history, or a family history in a first-born relative, of any medicalor psychiatric disorder, disease, condition, injury, symptoms or circumstance that,in the opinion of the principal investigator, may: (1) impact the risk profile ofTMS; (2) reduce the subject's ability to fulfill the study requirements as perprotocol; or (3) adversely impact the integrity of the data or the validity of thestudy results." Some examples include: epilepsy or seizure disorder(s), bipolardisorder or any psychiatric disorder associated with a risk of mania, intracranialpathology, traumatic brain injury, brain tumor, stroke, implanted medical devices ormetallic objects in the head, or moderate-severe heart disease

  • Pregnant according to the medical history or a urine pregnancy test; andmenstruating females who are heterosexually active and not using a highly effectiveform of contraception (tubal ligation, FDA-approved hormonal contraceptive, or anIUD)

  • Inability to undergo MRI.

  • Left handedness.

  • Is deemed to be at imminent risk of suicide according to the Ask Suicide-ScreeningQuestions (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 3months 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 anddose for 6 weeks with no planned changes over the study period)

Study Design

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: Transcranial Magnetic Stimulation: intermittent theta burst to dorsolateral prefrontal cortex
Phase:
Study Start date:
March 20, 2024
Estimated Completion Date:
July 31, 2025

Study Description

Pediatric OCD is a public health problem and many remain symptomatic even after receiving efficacious treatments. The success of exposure and response prevention (ERP), a first-line behavioral treatment, depends on the ability to refrain from compulsions during exposure tasks. Improving this "therapy critical behavior" is a potentially important strategy for ERP augmentation. Repetitive transcranial magnetic stimulation (rTMS) can be leveraged to stimulate healthier functioning of brain circuits underlying therapy critical behaviors. The overall objective of this project is to test whether augmenting ERP with rTMS over cortical nodes of select cortico-striatal circuits implicated in compulsivity can normalize connectivity and enhance response prevention in youth and young adults with OCD. This project will use a masked RCT design to test whether ERP+TMS engages 1) hypothesized circuits involved in compulsivity and 2) observed response prevention during ERP exposure tasks. Youth ages 12-21 years with OCD will complete a full course of ERP plus randomly assigned TMS regimens of sham, inhibitory theta burst stimulation (iTBS) to the dorsolateral prefrontal cortext (dlPFC), or continuous theta burst stimulation (cTBS) to the presupplementary motor area (pSMA; n=20 per group). Milestones for the R61 phase are determination that at least one active rTMS condition a) changes resting state functional connectivity in the hypothesized circuit within- and between-subjects and b) is safe and feasible.

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55414
    United States

    Active - Recruiting

  • Emma Pendleton Bradley Hospital

    Riverside, Rhode Island 02915
    United States

    Active - Recruiting

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