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Neurofeedback for Obsessive-Compulsive Disorder (OCD)

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Yale University
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02206945
First received: July 28, 2014
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention
Obsessive-Compulsive Disorder Behavioral: neurofeedback Behavioral: control feedback

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurofeedback of Activity in the Orbitofrontal Cortex for OCD

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 54
Study Start Date: July 2015
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neurofeedback
Two imaging sessions of neurofeedback.
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.
Placebo Comparator: control feedback
Two imaging sessions of feedback
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02206945

Contacts
Contact: Suzanne Wasylink 203-974-7523 suzanne.wasylink@yale.edu
Contact: Eileen Billingslea 203-974-7768 eileen.billingslea@yale.edu

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Michelle Hampson, PhD         
Sub-Investigator: Christopher Pittenger, MD,PhD         
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Michelle Hampson, PhD Yale School of Medicine
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02206945     History of Changes
Other Study ID Numbers: 0206017435-2
R01MH100068 ( U.S. NIH Grant/Contract )
Study First Received: July 28, 2014
Last Updated: December 7, 2016

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

ClinicalTrials.gov processed this record on August 18, 2017