Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback

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

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Stephan Taylor, MD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-18

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• United States

Study Locations