Neurofeedback for Obsessive-Compulsive Disorder (OCD)

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Neurofeedback of Activity in the Orbitofrontal Cortex for OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206945
• Other study ID #: 0206017435-2
• Secondary ID: R01MH100068
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: November 2021

Study information

• Verified date: February 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional connectivity patterns in the brain	Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.	Approximately 4 days pre-intervention
Other	Functional connectivity patterns in the brain	Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.	Approximately 4 days post-intervention
Other	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
Other	A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms		Approximately 4 weeks post-intervention
Other	Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety	Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety.	Approximately 4 days pre-intervention
Other	Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety.	Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety.	Approximately 4 days post-intervention
Primary	A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms		Immediately before intervention
Primary	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	Control over target brain area	Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.	Approximately 4 days pre-intervention
Secondary	Control over the target brain area.	Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.	Approximately 4 days post-intervention