TMS for Improving Response Inhibition in Adolescents With OCD

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Riverside, Rhode Island, United States, 02915
      • Emma Pendleton Bradley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report Symptom Question	Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions	post (within 1 hour after) intervention

Collaborators and Investigators

• Sponsor: Bradley Hospital
• Collaborators: University of Minnesota; Butler Hospital
• Investigators: Principal Investigator: Kristen Benito, PhD, Bradley Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: October 9, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 1697181; 5P20GM130452 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes