Clinical trial NCT02206945: Neurofeedback for Obsessive-Compulsive Disorder (OCD)
Official title: Neurofeedback of Activity in the Orbitofrontal Cortex for OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-08-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
timeFrame: Immediately before intervention
measure: A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
timeFrame: Approximately 4 days post-intervention
Secondary outcomes:
measure: Control over target brain area
timeFrame: Approximately 4 days pre-intervention
measure: Control over the target brain area.
timeFrame: Approximately 4 days post-intervention
Other outcomes:
measure: Functional connectivity patterns in the brain
timeFrame: Approximately 4 days pre-intervention
measure: Functional connectivity patterns in the brain
timeFrame: Approximately 4 days post-intervention
measure: A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
timeFrame: Approximately 2 weeks post-intervention
measure: A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
timeFrame: Approximately 4 weeks post-intervention
measure: Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety
timeFrame: Approximately 4 days pre-intervention
measure: Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety.
timeFrame: Approximately 4 days post-intervention
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Michelle Hampson, PhD
role: PRINCIPAL_INVESTIGATOR
References: