Using real-time brain imaging to help manage depression

Targeting Large-scale Networks in Depression With Real-time fMRI Neurofeedback

This study is testing a new way to help people with depression by using real-time brain scans to see if giving feedback on their brain activity can help them feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Michigan (Academic / other)
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT06050070 on ClinicalTrials.gov

What this trial studies

This study aims to develop a technique called real-time fMRI neurofeedback, which allows researchers to measure brain activity in participants with Major Depressive Disorder using a standard MRI scanner. By providing feedback signals that indicate brain activity in real time, the study seeks to help individuals better regulate their brain activity and potentially manage psychiatric symptoms. The study consists of two clinical phases, focusing on the activation of brain networks and the effectiveness of neurofeedback compared to sham feedback. The research is funded by the National Institutes of Health and conducted at the University of Michigan.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who meet the DSM-5 criteria for Major Depressive Disorder and have a PHQ9 score of 6 or higher.

Not a fit: Patients with active substance use disorders, severe suicidal ideation, or those who cannot tolerate MRI conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide patients with a novel method to regulate their brain activity and alleviate symptoms of depression.

How similar studies have performed: While the use of neurofeedback in mental health is an emerging field, this specific approach using real-time fMRI is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Meets The Diagnostic and Statistical Manual of Mental Disorders five (DSM5) criteria for Major Depressive Disorder, single or recurrent, active or in partial remission
* Patient Health Questionnaire (PHQ9) greater or equal (≥)6, and approximately (\~) 50% with PHQ9≥10
* If participants are taking antidepressant medications, on stable dosage for 4 weeks
* No history of active substance use disorder in the past 6 months
* Absence of suicidal thoughts with plans or intentions, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
* If a woman of child-bearing age, not pregnant or trying to become pregnant
* Ability to tolerate small, enclosed spaces without anxiety
* No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles (for example metal workers with exposures, protocol has more details), etc.
* Size compatible with scanner gantry (per protocol)
* Ability and willingness to give informed consent to participate.

Exclusion Criteria:

* Size not compatible with scanner
* Not meeting diagnostic criteria for bipolar disorder, schizophrenia, other psychosis, obsessive-compulsive disorder, active eating disorder or Post-traumatic stress disorder (PTSD)
* No history of serious neurological illness (including, but not limited to, seizures/epilepsy) or current medical condition that could compromise brain function, such as liver failure
* No history of closed head injury, e. g. loss of consciousness \> \~5 min, hospitalization, neurological sequela

Where this trial is running

Ann Arbor, Michigan

• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Stephan Taylor, MD — University of Michigan
• Study coordinator: Sophia Hovakimian

Conditions Major Depressive Disorder; Functional MRI; Neurofeedback