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Completed

NCT Number: NCT02206945

Neurofeedback for Obsessive-Compulsive Disorder (OCD)

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neurofeedback

Behavioral

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.

Control Feedback

Behavioral

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.

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Neurofeedback of Activity in the Orbitofrontal Cortex for OCD

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Aug 1, 2014
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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