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

NCT04941066 | Completed

• 1 other identifier: 2021-002
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression; Anxiety

Keywords

neurofeedback; real-time fMRI; rumination

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Changes in Depression subscale of Ruminative Responses Scale (RRS) scores

  Through study completion (average: 2 weeks)

• Changes in Reflection subscale of Ruminative Responses Scale (RRS) scores

  Through study completion (average: 2 weeks)

• Changes in sum of Brooding and Depression subscales of Ruminative Responses Scale (RRS) scores

  Through study completion (average: 2 weeks)

• Changes in total score of Ruminative Responses Scale (RRS) scores

  Through study completion (average: 2 weeks)

Other Outcomes (12)

• Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores

  Through study completion (average: 2 weeks)

• Changes in Hamilton Anxiety Rating Scale (HAM-A) scores

  Through study completion (average: 2 weeks)

• Changes in Patient Health Questionnaire (PHQ-9) scores

  Through study completion (average: 2 weeks)

Study Arms (2)

Active neurofeedback

EXPERIMENTAL

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

Behavioral: Active neurofeedback

Sham neurofeedback

SHAM COMPARATOR

Receiving artificially generated feedback signals.

Behavioral: Sham neurofeedback

Interventions

Active neurofeedback BEHAVIORAL

The session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity.

Active neurofeedback

Sham neurofeedback BEHAVIORAL

The session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal.

Sham neurofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74136, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Rumination Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders

Study Officials

• Salvador Guinjoan, MD, PhD

  Laureate Institute for Brain Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to a cognitive process-based real-time fMRI neurofeedback (CNF) or a sham condition.

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 28, 2021
• Study Start: March 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)