TMS for Improving Response Inhibition in Adolescents With OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title:

TMS for Improving Response Inhibition in Adolescents With OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104697
• Other study ID #: 1697181
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: January 2024
• Source: Bradley Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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)

Locations

Country	Name	City	State
United States	Emma Pendleton Bradley Hospital	Riverside	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Bradley Hospital	Butler Hospital, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in response time on stop trials of the stop signal task	Computerized task, where shorter response time (in seconds) indicates better performance	Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Primary	Change in frontocentral P3 amplitude on Electroencephalogram (EEG)	Electroencephalogram (EEG)	Change from pre (within 1 hour before) to post (within 1 hour after) intervention
Secondary	3-item self-report symptom questionnaire	self-rated mood and OCD symptoms on a 0-5 scale, where higher scores indicate more symptoms	post (within 1 hour after) intervention