NCT05934604

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to develop a technique called real time fMRI neurofeedback. This technique uses a functional 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. Therefore, this registration will include phase 2 at this time.

Detailed description

During the second phase of the project healthy participants (approximately 12) will have three study visits (two fMRIs) over 2-4 weeks. Note: As the study is a feasibility/development study, alterations of the task design for the primary outcome measures will be done to achieve objectives of developing at task that recruits from the target region (salience network). In phase 1 of the study, changes to the task are ongoing, and the same may occur for phase 2 in order to develop a viable neurofeedback paradigm. Therefore, detailed descriptions of the outcome measures are not entered at this time, as we don't know exactly what those are. When we do, the entry will be updated. Note: As of 7/26/2024, the study is rolling back from 'Completed' to 'Recruiting' status in order to include more healthy controls and temporarily resume active development of the task design.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
OTHER	Functional magnetic resonance imaging (fMRI)	Healthy subjects will complete two fMRI sessions after initial assessment and training in the Rest Focus Task (RFT). The first session will be the localizer session to identify the networks involved in switching in the RFT. The second fMRI session, real time functional magnetic resonance imaging neurofeedback (rtfMRI-NF) session, will use localizer information from the first fMRI session to develop a mask for the rtfMRI-NF, and deliver a neurofeedback (NF) stimulus while simultaneously measuring Blood Oxygenation Level Dependent (BOLD) activity for the STOP\>RECALL contrast.

Timeline

• Start date: 2023-10-09
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2023-07-07
• Last updated: 2024-11-08

Locations

1 site across 1 country: United States