Recruiting

Neurofeedback

Sponsor:

University of Michigan

Code:

NCT06050070

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

FMRI with sham controlled feedback

FMRI with real time feedback

Study Details

Brief summary:

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

Major Depressive Disorder

Study ID

NCT06050070

Start date

Mar 18, 2024

Status verified date

May, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

58 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

sham comparator: Sham controlled feedback

Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit.

experimental: Real-time neurofeedback

Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit.

Interventions

FMRI with sham controlled feedback

During the second fMRI, the study will introduce the real time fMRI neurofeedback part of the study. This is where subjects will use the activity from the brain to control the size of the circular pattern viewed in the first two visits. This is real time fMRI because the pattern will change, in real time, based on what the fMRI scan measures in the brain. Participants will be encouraged to make the circular pattern grow in size, just by thinking about it.

In order to see if the neurofeedback is really helping change the size of the circular pattern, the study team will have a control condition. In this controlled condition, subjects will see the circular pattern change, and the study team will ask participants to try and increase the size, except that the changing size will not actually be determined by your brain activity. This a called a sham condition because the feedback signal is not real.

FMRI with real time feedback

During the second fMRI, the study will introduce the real time fMRI neurofeedback part of the study. This is where subjects will use the activity from the brain to control the size of the circular pattern viewed in the first two visits. This is real time fMRI because the pattern will change, in real time, based on what the fMRI scan measures in the brain. Participants will be encouraged to make the circular pattern grow in size, just by thinking about it.

Primary outcome measure

  • Blood Oxygen Level Dependent (BOLD) signal change during the active > passive contrast during the localizer session [ Time Frame: Approximately 40 minutes (during MRI) ]
  • BOLD signal change during the active>passive contrast, comparing baseline with transfer runs (no NF in either), during the real time functional magnetic resonance imaging neurofeedback (rtfMRI-NF) session [ Time Frame: Approximately 40 minutes (during MRI) ]

Central Contacts and Locations

Central contacts

Sophia Hovakimian

734-232-0129shovakim@med.umich.edu

Laura Stchur, MSW

734-936-1323lmarine@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Sophia Hovakimian

734-232-0129shovakim@med.umich.edu

Laura Stchur, MSW

734-936-1323lmarine@med.umich.edu

Principal Investigator:

Stephan Taylor, MD

More Information

Sponsor

University of Michigan

Last update posted

Jun 8, 2026

Last verified

May, 2026

Keywords

  • Functional MRI
  • Neurofeedback

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-08.