7‑Tesla MRI neurofeedback to boost a key brain connection and reduce rumination in depression
Network-based Real-time Neurofeedback Using Ultra-high Field MRI to Reduce Rumination Levels in Depression
This program will try real-time 7‑Tesla MRI neurofeedback to strengthen a specific brain connection and reduce rumination in adults with major depressive disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05933148 on ClinicalTrials.gov |
What this trial studies
The team uses Dependency Network Analysis (DEPNA) to identify a reduced influence of the left medial orbitofrontal cortex (MOFC) on the right precuneus within the default mode network that is linked to rumination. Participants undergo real-time fMRI neurofeedback on a Siemens 7T scanner, receiving either active network-based feedback or sham feedback while behavioral and imaging measures are collected. The protocol trains up-regulation of MOFC→precuneus connectivity influence and measures changes in rumination and resting-state connectivity pre- and post-intervention. Adults aged 18–65 are recruited and screened with structured diagnostic interviews at Icahn School of Medicine at Mount Sinai.
Who should consider this trial
Good fit: Adults 18–65 with a current major depressive episode who can safely undergo a 7T MRI scan and give informed consent in English are the intended participants.
Not a fit: People with current or past psychotic or neurocognitive disorders, recent substance use disorder, pregnancy, contraindications to 7T MRI, current inpatient psychiatric hospitalization, or recent CNS-active medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could lower rumination and potentially reduce relapse risk in people with major depressive disorder.
How similar studies have performed: Previous real-time fMRI neurofeedback targeting single brain regions has shown mixed promise, while this DEPNA-based, network-targeted neurofeedback approach is novel and largely untested in MDD.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
New York, New York
- Icahn School Of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Yael Jacob, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Grace S. Butler, BA
- Email: grace.butler@mssm.edu
- Phone: (212) 585-4623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.