Clincosm LogoSign in Get a demo

TMS for Improving Response Inhibition in Adolescents With OCD

Sponsor
Bradley Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05104697
Collaborator
Butler Hospital (Other), University of Minnesota (Other)
25
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magnetic Stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocolInvestigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
TMS for Improving Response Inhibition in Adolescents With OCD
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: TMS at visit 1, Sham at visit 2

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in response time on stop trials of the stop signal task [Change from pre (within 1 hour before) to post (within 1 hour after) intervention]

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

  2. Change in frontocentral P3 amplitude on Electroencephalogram (EEG) [Change from pre (within 1 hour before) to post (within 1 hour after) intervention]

    Electroencephalogram (EEG)

Secondary Outcome Measures

  1. 3-item self-report symptom questionnaire [post (within 1 hour after) intervention]

    self-rated mood and OCD symptoms on a 0-5 scale, where higher scores indicate more symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emma Pendleton Bradley Hospital Riverside Rhode Island United States 02915

Sponsors and Collaborators

  • Bradley Hospital
  • Butler Hospital
  • University of Minnesota

Investigators

  • Principal Investigator: Kristen Benito, PhD, Bradley Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Kristen Benito, Associate Professor (Research), Bradley Hospital
ClinicalTrials.gov Identifier:
NCT05104697
Other Study ID Numbers:
  • 1697181
First Posted:
Nov 3, 2021
Last Update Posted:
Jul 11, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Obsessive-Compulsive Disorder

Study Results

No Results Posted as of Jul 11, 2022