Neurofeedback for Obsessive-Compulsive Disorder (OCD)

Neurofeedback of Activity in the Orbitofrontal Cortex for 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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: neurofeedback; Behavioral: 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: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms	Immediately before intervention
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms	Approximately 4 days post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Control over target brain area	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.	Approximately 4 days pre-intervention
Control over the target brain area.	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.	Approximately 4 days post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional connectivity patterns in the brain	Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.	Approximately 4 days pre-intervention
Functional connectivity patterns in the brain	Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.	Approximately 4 days post-intervention
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms		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		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	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.	Approximately 4 days pre-intervention
Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety.	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.	Approximately 4 days post-intervention

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Michelle Hampson, PhD, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): November 1, 2021
• Study Completion (ACTUAL): November 1, 2021

Study Registration Dates

• First Submitted: July 28, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (ESTIMATE): August 1, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 0206017435-2; R01MH100068 (NIH)