ClinicalTrials.gov
ClinicalTrials.gov Menu

Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Direct Current Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02704117
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : January 4, 2018
Sponsor:
Collaborators:
University of Rochester
Harvard University
University of Pittsburgh
University of Puerto Rico
Information provided by (Responsible Party):
Butler Hospital

Brief Summary:
The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial direct current stimulation (tDCS), 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
Obsessive-Compulsive Disorder Device: Transcranial direct current stimulation (tDCS) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neurocircuitry of OCD: Effects Of Modulation
Study Start Date : June 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
Cathodal transcranial direct current stimulation (tDCS) applied over the pre-supplementary motor area (pSMA), weekdays for approximately six weeks
Device: Transcranial direct current stimulation (tDCS)
The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device).




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) [ Time Frame: Baseline and 6 months ]

Secondary Outcome Measures :
  1. Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Baseline and 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current primary OCD diagnosis and current Y-BOCS total score of ≥16
  • 18-65 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 tDCS 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704117


Contacts
Contact: Benjamin Greenberg, MD, PhD (401) 455-6602 benjamin_greenberg@brown.edu
Contact: Brittney Blanchette (401) 455-6366 bblanchette@butler.org

Locations
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Benjamin Greenberg, MD, PhD    401-455-6602    benjamin_greenberg@brown.edu   
Sponsors and Collaborators
Butler Hospital
University of Rochester
Harvard University
University of Pittsburgh
University of Puerto Rico

Additional Information:
Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT02704117     History of Changes
Other Study ID Numbers: P50MH106435 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders