NCT04941066

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Laureate Institute for Brain Research, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depression
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-06-28
• Last updated: 2023-01-18

Locations

1 site across 1 country: United States