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OpenTrials
Completed

NCT Number: NCT05104697

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.

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Key information

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emma Pendleton Bradley Hospital

Riverside, Rhode Island, 02915, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Change in Response Time on Stop Trials of the Stop Signal Task

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

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

  2. Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG)

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

    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).

Secondary outcomes

  1. Self-report Symptom Question

    Time frame: post (within 1 hour after) intervention

    Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions

Sponsors and collaborators

Lead sponsor

Bradley Hospital

Other

Collaborators

  • Butler Hospital
  • University of Minnesota

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 3, 2021
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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