Neurofeedback for Obsessive-Compulsive Disorder (OCD)
Neurofeedback of Activity in the Orbitofrontal Cortex for OCD
2 other identifiers
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2014
CompletedFirst Posted
Study publicly available on registry
August 1, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedFebruary 11, 2022
February 1, 2022
6.3 years
July 28, 2014
February 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Control over target brain area
Approximately 4 days pre-intervention
Control over the target brain area.
Approximately 4 days post-intervention
Other Outcomes (6)
Functional connectivity patterns in the brain
Approximately 4 days pre-intervention
Functional connectivity patterns in the brain
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
- +3 more other outcomes
Study Arms (2)
neurofeedback
EXPERIMENTALTwo imaging sessions of neurofeedback.
control feedback
PLACEBO COMPARATORTwo imaging sessions of feedback
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Related Publications (1)
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.
PMID: 37722238DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Hampson, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2014
First Posted
August 1, 2014
Study Start
July 1, 2015
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
February 11, 2022
Record last verified: 2022-02