Neurocircuitry of OCD: Effects Of Modulation

Butler Hospital1 site in 1 country19 target enrollmentJune 2015

ConditionsObsessive-Compulsive Disorder

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Obsessive-Compulsive Disorder
Sponsor: Butler Hospital
Enrollment: 19
Locations: 1
Primary Endpoint: Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain stimulation might change the functioning of regions implicated in OCD, and thereby inform possible future therapeutic uses.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

February 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Butler Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Current primary OCD diagnosis and current Y-BOCS total score of ≥16
•18-70 years of age
•Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
•No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry
•Ongoing psychotherapy allowed if already established for three months or more before study entry

Exclusion Criteria

•History of primary psychotic disorder or bipolar disorder
•Present acute suicidality
•History of head injury, epilepsy, or other clinically significant neurological illness except tic disorders
•Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease
•Premorbid intelligence quotient (IQ) estimate \< 80
•Visual disturbance (\<20/40 Snellen visual acuity, corrected)
•Current, or alcohol or illicit substance abuse/dependence in the last 3 months
•Contraindications to TMS or MRI: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia
•Women who are pregnant or breastfeeding. All women participants of reproductive age are required to have a negative pregnancy test prior to enrollment and use medically acceptable birth control throughout the study (barrier and/or oral contraceptives)
•Current psychotic symptoms

Outcomes

Primary Outcomes

Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)

Time Frame: Baseline and 6 months