NCT06050070Completed
Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
Targeting Large-scale Networks in Depression With Real-time fMRI Neurofeedback
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 16 Sept 2023
- Start date
- 18 Mar 2024
- Primary completion date
- 7 Jul 2026
- Lead sponsor
- University of Michigan
- Diseases
- Depression
- NCT number
- NCT06050070
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 18 Mar 2024 to the primary completion date, 7 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Size not compatible with scanner
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.