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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05934604
• Other study ID #: HUM00228741
• Status: Completed
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria (phase 2 participants):

• Ability and willingness to give informed consent to participate

• Not taking any medication, prescription or non-prescription, with psychotropic effects (birth control medications allowed)

• If a woman of child-bearing age, not pregnant or trying to become pregnant

• No history of serious neurological illness (including, but not limited to, seizures/epilepsy) or current medical condition that could compromise brain function, such as liver failure

• No history of closed head injury (see protocol for more details)

• Ability to tolerate small, enclosed spaces without anxiety

• No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition

• Size compatible with scanner gantry

Exclusion Criteria (phase 2 participants):

• History of past or current mental illness (except for simple phobias), but prior history of substance dependence ok if in remission for greater than 5 years

Related Conditions & MeSH terms

• Depression
• Healthy Participants

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Oxygen Level Dependent (BOLD) signal change during the Focus greater (>) Rest contrast during the localizer session		Approximately 40 minutes (during MRI)
Primary	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)