RECRUITING

TMS + Exposure Therapy for Pediatric OCD

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Conditions

Obsessive-Compulsive Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2024-03-20
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05931913

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 12 and 21 years.
  2. * Presence of OCD, as indicated by a score of \> 16 on the Children's Yale-Brown Obsessive Compulsive Scale, indicating moderate or greater OCD symptoms.
  3. * Presence of motor compulsions on CY-BOCS compulsion checklist
  4. * English fluency to ensure comprehension of informed consent and study measures and instructions.
  1. * Decline to provide informed consent.
  2. * Has a personal history, or a family history in a first-born relative, of any medical or psychiatric disorder, disease, condition, injury, symptoms or circumstance that, in the opinion of the principal investigator, may: (1) impact the risk profile of TMS; (2) reduce the subject's ability to fulfill the study requirements as per protocol; or (3) adversely impact the integrity of the data or the validity of the study results." Some examples include: epilepsy or seizure disorder(s), bipolar disorder or any psychiatric disorder associated with a risk of mania, intracranial pathology, traumatic brain injury, brain tumor, stroke, implanted medical devices or metallic objects in the head, or moderate-severe heart disease
  3. * Pregnant according to the medical history or a urine pregnancy test; and menstruating females who are heterosexually active and not using a highly effective form of contraception (tubal ligation, FDA-approved hormonal contraceptive, or an IUD)
  4. * Inability to undergo MRI.
  5. * Left handedness.
  6. * Is deemed to be at imminent risk of suicide according to the Ask Suicide-Screening Questions (ASQ) (i.e. answers YES to ≥ one (1) of the four screening questions) and/or in the medical opinion of the investigator
  7. * History of, or risk factors for, neurocardiogenic syncope (history of syncope/ presyncope related to noxious stimuli, anxiety, micturation, or posture).
  8. * Concurrent psychotherapy of any kind for OCD.
  9. * Concurrent TMS or receipt of any TMS experimental or clinical treatment less than 3 months prior to enrollment.
  10. * Taking a medication deemed to pose high seizurogenic potential per physician review
  11. * Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the study period)

Contacts and Locations

Study Contact

Kristen Benito, PhD
CONTACT
410-432-1054
kbenito@lifespan.org
Christine Conelea, PhD
CONTACT
cconelea@umn.edu

Principal Investigator

Kristen Benito, PhD
PRINCIPAL_INVESTIGATOR
Emma Pendleton Bradley Hospital
Christine Conelea, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States
Emma Pendleton Bradley Hospital
Riverside, Rhode Island, 02915
United States

Collaborators and Investigators

Sponsor: Bradley Hospital

  • Kristen Benito, PhD, PRINCIPAL_INVESTIGATOR, Emma Pendleton Bradley Hospital
  • Christine Conelea, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-20
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2024-03-20
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Obsessive-Compulsive Disorder