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

Not Applicable

Completed

• Conditions: Healthy Participants
• Interventions: Other: Functional magnetic resonance imaging (fMRI)

• Registration Number: NCT05934604
• Lead Sponsor: University of Michigan

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-07-07
• Study Start: 2023-10-09
• Status Verified: 2024-11
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic resonance imaging (MRI) group	Functional magnetic resonance imaging (fMRI)	Healthy volunteers will have two functional magnetic resonance imaging scans (localizer session and the real time functional magnetic resonance imaging neurofeedback session).

Primary Outcome Measures

Name	Time	Method
Blood Oxygen Level Dependent (BOLD) signal change during the Focus greater (>) Rest contrast during the localizer session	Approximately 40 minutes (during MRI)
BOLD signal change during the Focus>Rest contrast, comparing baseline with transfer runs (no NF in either), during the rtfMRI-NF session	Approximately 40 minutes (during MRI)

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States