Neurofeedback for Obsessive-Compulsive Disorder (OCD)

NCT ID: NCT02206945

Last Updated: 2022-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2021-11-30

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.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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neurofeedback

Two imaging sessions of neurofeedback.

Group Type EXPERIMENTAL

neurofeedback

Intervention Type 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

Two imaging sessions of feedback

Group Type PLACEBO_COMPARATOR

control feedback

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Hampson, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Rance M, Zhao Z, Zaboski B, Kichuk SA, Romaker E, Koller WN, Walsh C, Harris-Starling C, Wasylink S, Adams T Jr, Gruner P, Pittenger C, Hampson M. Neurofeedback for obsessive compulsive disorder: A randomized, double-blind trial. Psychiatry Res. 2023 Oct;328:115458. doi: 10.1016/j.psychres.2023.115458. Epub 2023 Sep 3.

Reference Type DERIVED
PMID: 37722238 (View on PubMed)

Other Identifiers

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R01MH100068

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0206017435-2

Identifier Type: -

Identifier Source: org_study_id

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