Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination

Study Overview
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Brief Summary
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The purpose of this study is to assess the feasibility and efficacy of real-time fMRI neurofeedback for rumination.

Detailed Description
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Neuroimaging MRI techniques for measuring brain structure, tissue composition, and Blood Oxygenation Level Dependent functional Magnetic Resonance imaging (BOLD fMRI) will be used to measure task-dependent and task-independent brain hemodynamic and electrophysiological changes in human subjects with major depressive disorders (MDD). After being informed about the study and potential risks, all participants giving written informed consent will undergo one session of the cognitive process-based fMRI neurofeedback (CNF) targeting the rumination-related brain functional connectivity, and a one-week follow-up. Participants will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Active (receiving feedback from their own brain activity) or Sham (receiving artificially generated feedback).

Official Title
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Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Active neurofeedback
* Behavioral: Sham neurofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health DSM-5 diagnosis of major depressive disorder (MDD) Exclusion Criteria: General Exclusion Criteria: Pregnancy Medical Conditions: Moderate to severe traumatic brain injury (>30 min. loss of consciousness or >24 hours posttraumatic amnesia) or other neurocognitive disorder with evidence of neurological deficits. Presence of co-morbid medical conditions not limited to but including cardiovascular (e.g., history of acute coronary event, stroke) and neurological diseases (e.g., Parkinson's disease), as well as pain disorders. Presence of an uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or to put the study participant at undue risk. Psychiatric Disorders: Current severe suicidal ideation or attempt within the past 12 months. Psychosis Bipolar disorder Substance abuse or dependence within the previous 6 months Contraindications for MRI: Bodily implants of unsafe paramagnetic materials such as pace-makers and aneurysm clips. Claustrophobia that is severe enough to preclude MRI scanning. Medications: Evidence of recreational drug use from a urine test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to a cognitive process-based real-time fMRI neurofeedback (CNF) or a sham condition.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active neurofeedback<br>Receiving feedback signals from the rumination-related brain functional connectivity. | Behavioral: Active neurofeedback<br>* The session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity.<br>|
| Sham Comparator: Sham neurofeedback<br>Receiving artificially generated feedback signals. | Behavioral: Sham neurofeedback<br>* The session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional connectivity change between precuneus and right temporoparietal junction (rTPJ) | Functional connectivity between precuneus and rTPJ will be calculated and evaluated using fMRI BOLD percent signal change. | Through study completion (average: 2 weeks) | 
| Changes in Brooding subscale of Ruminative Responses Scale (RRS) scores | The RRS Brooding subscale is a self-report scale to measure brooding ruminative responses. A higher score indicates higher brooding ruminative responses with a maximum score of 20 and a minimum score of 5. | Through study completion (average: 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Depression subscale of Ruminative Responses Scale (RRS) scores | The RRS Depression subscale is a self-report scale to measure depressive ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 48 and a minimum score of 12. | Through study completion (average: 2 weeks) | 
| Changes in Reflection subscale of Ruminative Responses Scale (RRS) scores | The RRS Reflection subscale is a self-report scale to measure reflective ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 20 and a minimum score of 5. | Through study completion (average: 2 weeks) | 
| Changes in sum of Brooding and Depression subscales of Ruminative Responses Scale (RRS) scores | The RRS Brooding and Depression subscales are a self-report scale to measure brooding and depressive ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 68 and a minimum score of 17. | Through study completion (average: 2 weeks) | 
| Changes in total score of Ruminative Responses Scale (RRS) scores | The RRS is a self-report scale to measure ruminative responses. A higher score indicates higher ruminative responses with a maximum score of 88 and a minimum score of 22. | Through study completion (average: 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurofeedback, real-time fMRI, rumination