Clinical trial NCT04941066: Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination
Official title: Cognitive Process-based Real-time fMRI Neurofeedback in MDD and Rumination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: neurofeedback
real-time fMRI
rumination
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to a cognitive process-based real-time fMRI neurofeedback (CNF) or a sham condition.
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Functional connectivity change between precuneus and right temporoparietal junction (rTPJ)
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Brooding subscale of Ruminative Responses Scale (RRS) scores
timeFrame: Through study completion (average: 2 weeks)
Secondary outcomes:
measure: Changes in Depression subscale of Ruminative Responses Scale (RRS) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Reflection subscale of Ruminative Responses Scale (RRS) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in sum of Brooding and Depression subscales of Ruminative Responses Scale (RRS) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in total score of Ruminative Responses Scale (RRS) scores
timeFrame: Through study completion (average: 2 weeks)
Other outcomes:
measure: Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Hamilton Anxiety Rating Scale (HAM-A) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Patient Health Questionnaire (PHQ-9) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in State-trait Anxiety Inventory (STAI) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Metacognitions Questionnaire (MCQ-30) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Thought Control Questionnaire (TCQ) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Rosenberg Self-Esteem Scale (RSE) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Temporal Experience Of Pleasure Scale (TEPS) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Emotion Regulation Questionnaire (ERQ) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Changes in Positive And Negative Affect Schedule Extended (PANAS-X) scores
timeFrame: Through study completion (average: 2 weeks)
measure: Credibility Expectancy Questionnaire (CEQ) score
timeFrame: Through study completion (average: 2 weeks)
measure: Post Neurofeedback Questionnaire score
timeFrame: Through study completion (average: 2 weeks)
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Salvador Guinjoan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: