Neurofeedback for Obsessive-Compulsive Disorder (OCD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neurofeedback of Activity in the Orbitofrontal Cortex for OCD

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: neurofeedback
* Behavioral: control feedback


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neurofeedback<br>Two imaging sessions of neurofeedback. | Behavioral: neurofeedback<br>* 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.<br>|
| Placebo Comparator: control feedback<br>Two imaging sessions of feedback | Behavioral: control feedback<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |