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

Not Applicable

Completed

• Conditions: Anxiety; Depression
• Interventions: Behavioral: Active neurofeedback; Behavioral: Sham neurofeedback

• Registration Number: NCT04941066
• Lead Sponsor: Laureate Institute for Brain Research, Inc.

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-28
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Good general health
• DSM-5 diagnosis of major depressive disorder (MDD)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active neurofeedback	Active neurofeedback	Receiving feedback signals from the rumination-related brain functional connectivity.
Sham neurofeedback	Sham neurofeedback	Receiving artificially generated feedback signals.

Primary Outcome Measures

Name	Time	Method
Changes in Brooding subscale of Ruminative Responses Scale (RRS) scores	Through study completion (average: 2 weeks)	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.
Functional connectivity change between precuneus and right temporoparietal junction (rTPJ)	Through study completion (average: 2 weeks)	Functional connectivity between precuneus and rTPJ will be calculated and evaluated using fMRI BOLD percent signal change.

Secondary Outcome Measures

Name	Time	Method
Changes in sum of Brooding and Depression subscales of Ruminative Responses Scale (RRS) scores	Through study completion (average: 2 weeks)	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.
Changes in total score of Ruminative Responses Scale (RRS) scores	Through study completion (average: 2 weeks)	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.
Changes in Depression subscale of Ruminative Responses Scale (RRS) scores	Through study completion (average: 2 weeks)	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.
Changes in Reflection subscale of Ruminative Responses Scale (RRS) scores	Through study completion (average: 2 weeks)	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.

Trial Locations

Locations (1)

Laureate Institute for Brain Research; 🇺🇸 Tulsa, Oklahoma, United States