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

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ClinicalTrials.gov Identifier: NCT02704117
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
University of Rochester
Harvard University
University of Pittsburgh
University of Puerto Rico
Information provided by (Responsible Party):
Butler Hospital

Tracking Information
First Submitted Date  ICMJE February 29, 2016
First Posted Date  ICMJE March 9, 2016
Last Update Posted Date March 4, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2016)
Change in activation of pSMA/dACC on fMRI during the Multi-Source Interference task [ Time Frame: Baseline and 6 months ]
Change History Complete list of historical versions of study NCT02704117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2016)
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: Baseline and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic Stimulation
Official Title  ICMJE Neurocircuitry of OCD: Effects Of Modulation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE 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 Name: Continuous Theta Burst Stimulation (cTBS)
Study Arms  ICMJE Experimental: TMS
Transcranial Magnetic Stimulation applied over the pre-supplementary motor area (pSMA), for ten sessions, Monday through Friday, over the course of two weeks.
Intervention: Device: Transcranial Magentic Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2016)
20
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Benjamin Greenberg, MD, PhD (401) 455-6602 benjamin_greenberg@brown.edu
Contact: Christina Erickson (401) 455-6366 coerickson@butler.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02704117
Other Study ID Numbers  ICMJE P50MH106435( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Butler Hospital
Study Sponsor  ICMJE Butler Hospital
Collaborators  ICMJE
  • University of Rochester
  • Harvard University
  • University of Pittsburgh
  • University of Puerto Rico
Investigators  ICMJE Not Provided
PRS Account Butler Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP