Network Neurofeedback Using 7-Tesla MRI to Reduce Rumination Levels in Depression (NCT05933148) | Clinical Trial Compass
SuspendedNot Applicable
Network Neurofeedback Using 7-Tesla MRI to Reduce Rumination Levels in Depression
Stopped: Technical problem with the MRI machine post processing in real-time. A new 7T MRI scanner will be installed by January 2027.
United States80 participantsStarted 2023-07-12
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently suspended — do you know why it was suspended, and whether it's likely to resume or if I should focus my energy on other options?
2This study uses a 7-Tesla MRI scanner for neurofeedback, which is much more powerful than a standard MRI — do you think I'm a good candidate for that kind of procedure given my current health, and are there any risks I should know about specific to high-field MRI?
3The trial is measuring changes in rumination using a self-reported questionnaire called the Rumination Response Style — how meaningful would a reduction in rumination actually be for someone with my level of depression, compared to what standard treatments like medication or therapy might offer?
4Since this trial doesn't have a traditional phase listed, it seems more exploratory — does that mean there's less known about whether neurofeedback actually helps with depression, and how would you weigh that uncertainty against starting a proven treatment now?
5If this trial does reopen and I were considered for it, how intensive would the 7-Tesla MRI neurofeedback sessions likely be in terms of time and travel, and is that realistically manageable alongside keeping up with my regular care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Self-reported rumination related to negative affect as measured by Rumination Response Style (RRS)
Timeframe: Pre-Neurofeedback (day 0) and Post-Neurofeedback (MRI assessment day 1)