RecruitingNot ApplicableNCT06050070

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

Sponsor

University of Michigan

Enrollment

58 participants

Start Date

Mar 18, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study uses real-time brain scan feedback (fMRI neurofeedback) to help people with depression learn to control brain activity associated with low mood. Participants watch their own brain activity on a screen and practice mental techniques to shift it in a healthier direction — no medication required. **You may be eligible if...** - You have been diagnosed with major depressive disorder (active or partially in remission) - Your depression score on a standard questionnaire is moderate or higher - If taking antidepressants, your dose has been stable for at least 4 weeks - You have no active substance use disorder in the past 6 months - You are comfortable in small, enclosed spaces (like an MRI machine) - You have no metal implants in your body **You may NOT be eligible if...** - You have active thoughts of suicide with a plan - You are pregnant or trying to become pregnant - You have metal in your body incompatible with MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERFMRI 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.

OTHERFMRI with real time feedback