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Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation

Sponsor
Butler Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02704117
Collaborator
University of Rochester (Other), Harvard University (Other), University of Pittsburgh (Other), University of Puerto Rico (Other)
30
Enrollment
1
Location
1
Arm
88
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Magentic Stimulation
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Neurocircuitry of OCD: Effects Of Modulation
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation applied over the pre-supplementary motor area (pSMA), for ten sessions, Monday through Friday, over the course of two weeks.

Device: Transcranial Magentic Stimulation
This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks
Other Names:
  • Continuous Theta Burst Stimulation (cTBS)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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) [Baseline and 6 months]

    Secondary Outcome Measures

    1. Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [Baseline and 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    • An increased risk of seizure, determined by history

    • Medications judged to notably affect cortical excitability e.g., anticonvulsants or high-dose benzodiazepines (> 4 mg/day of clonazepam or equivalent)

    • Predominant hoarding symptoms

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Butler Hospital Providence Rhode Island United States 02906

    Sponsors and Collaborators

    • Butler Hospital
    • University of Rochester
    • Harvard University
    • University of Pittsburgh
    • University of Puerto Rico

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Butler Hospital
    ClinicalTrials.gov Identifier:
    NCT02704117
    Other Study ID Numbers:
    • P50MH106435
    First Posted:
    Mar 9, 2016
    Last Update Posted:
    Sep 23, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:
    Compulsive Personality Disorder
    Obsessive-Compulsive Disorder

    Study Results

    No Results Posted as of Sep 23, 2021