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

Major Depressive Disorder Clinical Trial

Official title: Targeting Large-scale Networks in Depression With Real-time fMRI Neurofeedback

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Part 3/Phase 3 study hypothesis are:

• Rest Focus Task (RFT) will activate brain networks at the individual subject level to provide a viable signal for Neurofeedback (NF)

• At the group level, RFT in the Active>Passive contrast will activate canonically defined salience network

• Neurofeedback-reinforced practice over the session will increase RFT activation over the course of the training session, comparing RFT activation, without NF, before and after NF runs.

• Valid Neurofeedback will increase RFT activation more compared to sham NF (assessed during the no-NF session). ;

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT06050070
• Study type: Interventional
• Source: University of Michigan
• Contact: Sophia Hovakimian
• Phone: 734-232-0129
• Email: shovakim@med.umich.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Completion date: December 2025