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

NCT05933148 | Recruiting FDA Device

• 1 other identifier: STUDY-22-00048
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)

  The RRS measures ruminative responses to depressed mood. The content of the items is related to depressive cognitions and their possible causes and consequences. Total scores on the RSS can range from 22 to 88, with higher scores corresponding to higher levels of rumination.

  Pre-Neurofeedback (day 0) and Post-Neurofeedback (MRI assessment day 1)

Secondary Outcomes (16)

• Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)

  Pre-MRI Scan at screening (day 0)

• Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)

  Post-MRI scan at follow up visit 24 hours

• Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)

  Post-MRI scan at follow up visit day 7

• Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)

  Post-MRI scan at follow up visit day 30

• Self-reported rumination related to negative affect as measured by Perceive Stress Scale (PSS)

  Pre-MRI Scan at screening (day 0)

Study Arms (2)

Active Neurofeedback

ACTIVE COMPARATOR

Participants randomized to Active neurofeedback will receive real-time data depicting MOFC-precuneus brain activity while in the scanner.

Device: Siemens 7T MRI

Sham Neurofeedback

SHAM COMPARATOR

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.

Device: Sham Neurofeedback

Interventions

Siemens 7T MRI DEVICE

The active neurofeedback session will be done within the 7T MRI.

Also known as: fMRI

Active Neurofeedback

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.

Sham Neurofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-65 years who either meet DSM-5 Axis Disorders (SCID) or the Mini International Neuropsychiatric Interview (MINI) for major depressive disorder (MDD) with a current major depressive episode OR does not meet for any current or past psychiatric diagnoses
• Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process

You may not qualify if:

• Any current or history of schizophrenia or other psychotic disorder, neurodevelopmental disorder, or neurocognitive disorder for patients, active substance use disorder within the past 6 months
• Unstable medical illness, concomitant use of any medication with central nervous system activity within 1 week of MRI scan
• Pregnancy
• Patients who are currently hospitalized in the inpatient psychiatric units at Mount Sinai Hospital or involuntarily admitted/court-ordered
• Subjects judged to be at serious and imminent suicidal or homicidal risk by the study-affiliated psychiatrist or another MD, and contradictions to MRI

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School Of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yael Jacob, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace S. Butler, BA

CONTACT

(212) 585-4623; grace.butler@mssm.edu

Rachel Krasner, BA

CONTACT

rachel.krasner@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: Single-blind sham-controlled randomized trial

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 6, 2023
• Study Start: July 12, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)