Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination
NCT ID: NCT04941066
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2021-03-01
2022-03-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Active neurofeedback
Receiving feedback signals from the rumination-related brain functional connectivity.
Active neurofeedback
The session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity.
Sham neurofeedback
Receiving artificially generated feedback signals.
Sham neurofeedback
The session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal.
Interventions
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Active neurofeedback
The session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity.
Sham neurofeedback
The session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal.
Eligibility Criteria
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Inclusion Criteria
* DSM-5 diagnosis of major depressive disorder (MDD)
Exclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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Laureate Institute for Brain Research, Inc.
OTHER
Responsible Party
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Principal Investigators
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Salvador Guinjoan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Laureate Institute for Brain Research
Locations
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Laureate Institute for Brain Research
Tulsa, Oklahoma, United States
Countries
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Other Identifiers
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2021-002
Identifier Type: -
Identifier Source: org_study_id
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