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Clinical Trials/NCT02206945
NCT02206945
Completed
Not Applicable

Neurofeedback of Activity in the Orbitofrontal Cortex for OCD

Yale University1 site in 1 country44 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obsessive-Compulsive Disorder
Sponsor
Yale University
Enrollment
44
Locations
1
Primary Endpoint
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
November 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms

Time Frame: Approximately 4 days post-intervention

Secondary Outcomes

  • Control over target brain area(Approximately 4 days pre-intervention)
  • Control over the target brain area.(Approximately 4 days post-intervention)

Study Sites (1)

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