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Neurofeedback for Obsessive-Compulsive Disorder (OCD)

Yale University logo

Yale University

Status

Completed

Conditions

Obsessive-Compulsive Disorder

Treatments

Behavioral: neurofeedback
Behavioral: control feedback

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02206945
0206017435-2
R01MH100068 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

44 participants in 2 patient groups, including a placebo group

neurofeedback
Experimental group
Description:
Two imaging sessions of neurofeedback.
Treatment:
Behavioral: neurofeedback
control feedback
Placebo Comparator group
Description:
Two imaging sessions of feedback
Treatment:
Behavioral: control feedback

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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