Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination (CNF-rumination)

Laureate Institute for Brain Research (LIBR)

Status: Completed

Conditions: Depression; Anxiety

Treatments: Behavioral: Sham neurofeedback; Behavioral: Active neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04941066

2021-002

Details and patient eligibility

About

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

Full 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).

Enrollment: 44 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

Active neurofeedback

Experimental group

Description:

Receiving feedback signals from the rumination-related brain functional connectivity.

Treatment:

Behavioral: Active neurofeedback

Sham neurofeedback

Sham Comparator group

Description:

Receiving artificially generated feedback signals.

Treatment:

Behavioral: Sham neurofeedback