TMS for Improving Response Inhibition in Adolescents With OCD

NCT05104697 | Completed Results DMC FDA Device

• 2 other identifiers: 16971815P20GM130452
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits, improves response inhibition, and reduces compulsions in adolescents with OCD.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Response Time on Stop Trials of the Stop Signal Task

  Computerized task, where shorter response time (in milliseconds) indicates better performance

  Change from pre (within 1 hour before) to post (within 1 hour after) intervention

• Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG)

  Electroencephalogram (EEG) measured amplitude on successful stop trials of the stop signal task (SST). Calculated by averaging the epochs of successful stop trials time-locked to the stop signal from the midline electrode (Cz).

  Change from pre (within 1 hour before) to post (within 1 hour after) intervention

Secondary Outcomes (1)

• Self-report Symptom Question

  post (within 1 hour after) intervention

Study Arms (2)

TMS at visit 1, Sham at visit 2

OTHER

At visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location.

Device: Transcranial Magnetic Stimulation

Sham at visit 1, TMS at visit 2

OTHER

At visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced)

Sham at visit 1, TMS at visit 2; TMS at visit 1, Sham at visit 2

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 13-18 years
• Presence of OCD, as indicated by score on the Children's Yale-Brown Obsessive-Compulsive Scale
• Patient and one parent speak English fluently (to ensure comprehension of study measures and instructions
• Right-handed
• If taking psychotropic medications, these have been stable for \> 6 weeks and are expected to remain stable for the approximately 3-week study protocol
• If currently in psychotherapy, symptom improvement has plateaued (no improvement in the past 6 weeks and symptoms expected to remain stable for the approximately 3-week study protocol)

You may not qualify if:

• Medical conditions contraindicated for TMS or EEG, including history of intracranial pathology, increased intracranial pressure, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, possible pregnancy (female of childbearing age not using effective contraception), or any other serious medical condition (note that medical history will be reviewed by a study physician prior to TMS administration)
• Metal in the head, except mouth (e.g., cochlear implant, implanted brain stimulators, aneurysm clips)
• Active suicidality or psychosis
• Existing diagnosis of Bipolar disorder, Autism Spectrum Disorder, mental retardation, or cognitive disability
• Substance abuse or dependence
• Taking a stimulant medication (and unwilling to forgo on study visit days)
• Taking medication with the potential to lower seizure threshold (e.g., neuroleptics, antipsychotics)
• Patient is a ward of the state
• Family history of epilepsy
• History of syncope

Sponsors & Collaborators

• Bradley Hospital: lead
• Butler Hospital: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Emma Pendleton Bradley Hospital

Riverside, Rhode Island, 02915, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

This trial has a small sample size; results will need to be confirmed in a larger sample.

Results Point of Contact

• Title: Dr. Kristen Benito
• Organization: Emma Pendleton Bradley Hospital

kbenito@lifespan.org

401-432-1054

Study Officials

• Kristen Benito, PhD

  Bradley Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Model Details: Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol

Study Record Dates

• First Submitted: October 9, 2021
• First Posted: November 3, 2021
• Study Start: April 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 28, 2025
• Results First Posted: January 28, 2025

Record last verified: 2025-01

Locations

US (1)