Actively Recruiting
Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
Led by University of Michigan · Updated on 2025-10-06
70
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to develop a technique called real time fMRI neurofeedback. This technique uses a regular MRI scanner, except that special software allows the researchers to measure activity in participants brain, using fMRI, and then give information, in the form of a feedback signal, which indicates brain activity in real time, while in the MRI scanner. The larger goal of this study is to develop ways to help people, including those with depression, better regulate brain activity. The researchers think that this may be helpful in managing psychiatric symptoms. This study design has three phases, however, only two phases (phase 2 and 3) are considered to be a clinical trial. Phase 2 (part 2) was registered and is NCT05934604. This is the phase 3 (part 3) for this project and is funded by the National Institutes of Health.
CONDITIONS
Official Title
Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets DSM-5 criteria for Major Depressive Disorder, single or recurrent, active or in partial remission
- Patient Health Questionnaire (PHQ9) score of 6 or higher, with about 50% scoring 10 or higher
- If on antidepressants, stable dosage for at least 4 weeks
- No active substance use disorder in the past 6 months
- No suicidal thoughts with plans or intentions as assessed by Columbia Suicide Severity Rating Scale
- If 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 in or on the body that could interfere with MRI
- Body size compatible with MRI scanner gantry
- Ability and willingness to provide informed consent
You will not qualify if you...
- Body size not compatible with MRI scanner
- Diagnosed with bipolar disorder, schizophrenia, other psychosis, obsessive-compulsive disorder, active eating disorder, or post-traumatic stress disorder
- History of serious neurological illness including seizures or epilepsy
- Current medical condition that may affect brain function such as liver failure
- History of closed head injury with loss of consciousness greater than approximately 5 minutes, hospitalization, or neurological complications
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
S
Sophia Hovakimian
CONTACT
L
Laura Stchur, MSW
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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