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Neurofeedback for Obsessive-Compulsive Disorder (OCD)

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: NCT02206945
Recruitment Status : Active, not recruiting
First Posted : August 1, 2014
Last Update Posted : June 30, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE July 28, 2014
First Posted Date  ICMJE August 1, 2014
Last Update Posted Date June 30, 2020
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2014)
  • A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms [ Time Frame: Immediately before intervention ]
  • A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms [ Time Frame: Approximately 4 days post-intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
  • A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms [ Time Frame: Baseline ]
  • A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms [ Time Frame: up to 4 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2014)
  • Control over target brain area [ Time Frame: Approximately 4 days pre-intervention ]
    Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
  • Control over the target brain area. [ Time Frame: Approximately 4 days post-intervention ]
    Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
  • Control over target brain area [ Time Frame: up to 4 days ]
    Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
  • Control over the target brain area. [ Time Frame: up to 4 days ]
    Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
Current Other Pre-specified Outcome Measures
 (submitted: April 13, 2016)
  • Functional connectivity patterns in the brain [ Time Frame: Approximately 4 days pre-intervention ]
    Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
  • Functional connectivity patterns in the brain [ Time Frame: Approximately 4 days post-intervention ]
    Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
  • A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms [ Time Frame: Approximately 2 weeks post-intervention ]
  • A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms [ Time Frame: Approximately 4 weeks post-intervention ]
  • Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety [ Time Frame: Approximately 4 days pre-intervention ]
    Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety.
  • Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety. [ Time Frame: Approximately 4 days post-intervention ]
    Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety.
Original Other Pre-specified Outcome Measures
 (submitted: July 31, 2014)
  • Functional connectivity patterns in the brain [ Time Frame: up to 4 days ]
    Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
  • A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms [ Time Frame: two weeks after feedback is completed ]
  • A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms [ Time Frame: four weeks after feedback. ]
 
Descriptive Information
Brief Title  ICMJE Neurofeedback for Obsessive-Compulsive Disorder (OCD)
Official Title  ICMJE Neurofeedback of Activity in the Orbitofrontal Cortex for OCD
Brief Summary The aim of this study is to train patients with obsessive-compulsive disorder to control a region of their brain that has been associated with their symptoms. Patients in the experimental group will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control activity in the region during these feedback sessions. A separate group of patients will be given a control form of feedback that we do not believe can have clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms more than the control feedback.
Detailed Description Original study design recruiting controls who were matched to the experimental group was changed to a randomized design prior to enrollment of the first participant.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Behavioral: neurofeedback
    Subject provided with feedback of activity in target brain area in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.
  • Behavioral: control feedback
    Subject provided with a control/placebo type of feedback in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.
Study Arms  ICMJE
  • Experimental: neurofeedback
    Two imaging sessions of neurofeedback.
    Intervention: Behavioral: neurofeedback
  • Placebo Comparator: control feedback
    Two imaging sessions of feedback
    Intervention: Behavioral: control feedback
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2014)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Primary Diagnosis of Current OCD, based on Diagnostic and Statistical Manual (DSM-IV) criteria, a Y-BOCS (Yale-Brown Obsessive-Compulsive Scale) score >=16
  • Principle OCD symptoms- Primary symptoms must be either Cleaning/Contamination or Checking; other symptoms okay
  • Unmedicated (or medications stable for 8 weeks).
  • Research group must be able to identify a target region in the orbitofrontal cortex that is related to symptoms

Exclusion Criteria:

  • Active Psychosis; Pervasive Developmental Disorder ; epilepsy or other major neurological disorder
  • History of major head trauma or psychosurgery
  • Active Substance Abuse within 6 months
  • Seizure disorder or other significant neurological disorder
  • Active Suicidality
  • Pregnancy
  • severe claustrophobia, ferromagnetic metal in the body, a pacemaker or defibrillator, or any other condition that would make MRI scanning unsafe or inappropriate
  • any psychotropic medication other than a selective serotonin reuptake inhibitor (SSRI) antidepressant, anafranil, or a low-dose hypnotic or anxiolytic taken on an as-needed basis
  • active cognitive/behavioral therapy initiated within the last 3 months (continuation of established maintenance therapy that has been going on for longer than 3 months will not be grounds for exclusion)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02206945
Other Study ID Numbers  ICMJE 0206017435-2
R01MH100068 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Michelle Hampson, PhD Yale School of Medicine
PRS Account Yale University
Verification Date June 2020

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