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Neurocircuitry of Obsessive-Compulsive Disorder: Modulation by Transcranial Magnetic 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02704117
Recruitment Status : Active, not recruiting
First Posted : March 9, 2016
Last Update Posted : December 2, 2022
Sponsor:
Collaborators:
University of Rochester
Harvard University
University of Pittsburgh
University of Puerto Rico
Information provided by (Responsible Party):
Butler Hospital

Study Description
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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
Obsessive-Compulsive Disorder Device: Transcranial Magentic Stimulation Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 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 : June 2015
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Continuous Theta Burst Stimulation (cTBS)


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 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
  • 18-70 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
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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


Locations
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United States, Rhode Island
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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT02704117    
Other Study ID Numbers: P50MH106435 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: December 2022
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders