Neurofeedback for Obsessive-Compulsive Disorder (OCD)

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Behavioral: control feedback; Behavioral: neurofeedback

• Registration Number: NCT02206945
• Lead Sponsor: Yale University

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 Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-07-31
• Study First Posted: 2014-08-01
• Study Start: 2015-07
• Primary Completion: 2021-11
• Study Completion: 2021-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control feedback	control feedback	Two imaging sessions of feedback
neurofeedback	neurofeedback	Two imaging sessions of neurofeedback.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Control over target brain area	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.	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.

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States