Obsessive-Compulsive DisorderNCT02206945
Neurofeedback for Obsessive-Compulsive Disorder (OCD)
A study testing neurofeedback in people with Obsessive-Compulsive Disorder, run by Yale University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: Neurofeedback of Activity in the Orbitofrontal Cortex for OCD
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- neurofeedback, control feedback
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurofeedbackBehavioural
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 feedbackBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| neurofeedback | Experimental | Two imaging sessions of neurofeedback. Receives: Behavioral: neurofeedback |
| control feedback | Placebo comparator | Two imaging sessions of feedback Receives: Behavioral: control feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
Measured: Immediately before intervention
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
Measured: Approximately 4 days post-intervention
Secondary outcomes (2)
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.
Measured: Approximately 4 days pre-intervention
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.
Measured: Approximately 4 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJul 2015
- Primary completionNov 2021
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michelle Hampson, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206945
- Sponsor's protocol ID
- 0206017435-2
- Other IDs
- R01MH100068
- Status last verified
- Feb 2022
- First submitted
- 28 Jul 2014
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37722238
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback of Activity in the Orbitofrontal Cortex for OCD
- ClinicalTrials.gov ID
- NCT02206945
- Acronym / sponsor ID
- 0206017435-2
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2015
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 1 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neurofeedback | Experimental | Behavioral: neurofeedbackTwo imaging sessions of neurofeedback. |
| control feedback | Placebo comparator | Behavioral: control feedbackTwo imaging sessions of feedback |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neurofeedbackSubject 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. | Behavioural | neurofeedback |
| control feedbackSubject 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. | Behavioural | control feedback |
Primary outcome
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms
Time frame: Immediately before intervention
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
2 secondary outcomes
Control over target brain area
Time frame: Approximately 4 days pre-intervention
Control over the target brain area.
Time frame: Approximately 4 days post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Derived from this study: PubMed 37722238Rance 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Hampson, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neurofeedback in people with Obsessive-Compulsive Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms (time frame: Immediately before intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02206945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.