Network Neurofeedback Using 7-Tesla MRI to Reduce Rumination Levels in Depression

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Siemens 7T MRI — DEVICE
  The active neurofeedback session will be done within the 7T MRI.
• Sham Neurofeedback — DEVICE
  The sham Neurofeedback resembles the active condition but participants will not see their own brain activity and will instead view a past participant's active feedback from their same population group.

Study Details

Patients with major depressive disorder (MDD) exhibit increased levels of rumination (i.e. repetitive thinking and focus on negative mood states) which have been found to increase the risk of depressive relapse. The ability to reduce rumination levels among these patients is greatly needed. Rumination is known to be associated with the default mode network (DMN) region activity. Implementing the Dependency Network Analysis (DEPNA), a recently developed method by the research team to quantify the connectivity influence of network nodes, found that rumination was significantly associated with lower connectivity influence of the left medial orbitofrontal cortex (MOFC) on the right precuneus, both key regions within the DMN. This study implements the first real-time fMRI neurofeedback (Rt-fMRI-NF) network-based protocol for up-regulation of the MOFC influence on the precuneus in patients with MDD to reduce rumination levels. This will allow for more accurate explicit brain connections modulation than the standard single brain region activity; creating a larger opportunity for target clinical neuromodulation treatment in individuals with MDD.

Key Dates

Start date

Jul 12, 2023

Status verified

Aug 2025

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Active Neurofeedback
  Participants randomized to Active neurofeedback will receive real-time data depicting MOFC-precuneus brain activity while in the scanner.
• Sham Comparator: Sham Neurofeedback
  Participants randomized to the Sham neurofeedback control group will receive the feedback of a prior scanned participant's active MOFC-precuneus up-regulation and not their own brain activity. This condition will still visually resemble the active conditions.

Primary Outcome Measure

Change in Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS) [ Time Frame: Pre-Neurofeedback (day 0) and Post-Neurofeedback (MRI assessment day 1) ]

Central Contacts

• Grace S. Butler, BA
  (212) 585-4623
  [email protected]
• Rachel Krasner, BA
  [email protected]

Locations (1)

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