search
Back to results

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

Primary Purpose

Major Depressive Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FMRI with sham controlled feedback
FMRI with real time feedback
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring Functional MRI, Neurofeedback

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets The Diagnostic and Statistical Manual of Mental Disorders five (DSM5) criteria for Major Depressive Disorder, single or recurrent, active or in partial remission Patient Health Questionnaire (PHQ9) greater or equal (≥)6, and approximately (~) 50% with PHQ9≥10 If participants are taking antidepressant medications, on stable dosage for 4 weeks No history of active substance use disorder in the past 6 months Absence of suicidal thoughts with plans or intentions, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) If a woman of child-bearing age, not pregnant or trying to become pregnant 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, e. g. aneurysm clips, retained particles (for example metal workers with exposures, protocol has more details), etc. Size compatible with scanner gantry (per protocol) Ability and willingness to give informed consent to participate. Exclusion Criteria: Size not compatible with scanner Not meeting diagnostic criteria for bipolar disorder, schizophrenia, other psychosis, obsessive-compulsive disorder, active eating disorder or Post-traumatic stress disorder (PTSD) 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, e. g. loss of consciousness > ~5 min, hospitalization, neurological sequela

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham controlled feedback

Real-time neurofeedback

Arm Description

Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit.

Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit.

Outcomes

Primary Outcome Measures

Blood Oxygen Level Dependent (BOLD) signal change during the active > passive contrast during the localizer session
Using standard pre-processing pipelines, the general linear model, convolved with the hemodynamic response function, will be used to predict change in BOLD signal for the contrast of the active compared to the passive conditions. Z-transformed t-statistics will be corrected for multiple comparisons in the region of interest (salience network)
BOLD signal change during the active>passive contrast, comparing baseline with transfer runs (no NF in either), during the real time functional magnetic resonance imaging neurofeedback (rtfMRI-NF) session
Same processing as outcome measure 2, except the contrast of active>passive will itself be contrasted within the session (baseline compared to transfer run)

Secondary Outcome Measures

Full Information

First Posted
September 16, 2023
Last Updated
October 5, 2023
Sponsor
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT06050070
Brief Title
Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback
Official Title
Targeting Large-scale Networks in Depression With Real-time fMRI Neurofeedback
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed Description
Part 3/Phase 3 study hypothesis are: Recall Stop Task (RST) will activate brain networks at the individual subject level to provide a viable signal for Neurofeedback (NF) At the group level, RST in the Active>Passive contrast will activate canonically defined salience network Neurofeedback -reinforced practice over the session will increase RST activation over the course of the training session, comparing RST activation, without NF, before and after NF runs. Valid Neurofeedback will increase RST activation more compared to sham NF (assessed during the no-NF session).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Functional MRI, Neurofeedback

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to sham or active feedback conditions, using block randomization stratified by gender, in a 50:50 allocation.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham controlled feedback
Arm Type
Sham Comparator
Arm Description
Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit.
Arm Title
Real-time neurofeedback
Arm Type
Experimental
Arm Description
Subjects will complete three visits with one or two fMRI sessions after initial assessment and training visit. The first session will be to introduce practice tasks using the mock scanner. In the second visit participants will have an fMRI. The study team will review the fMRI results to decide if participants will continue on the study (must exhibit a specific pattern of activation) and have the second fMRI at the third visit.
Intervention Type
Other
Intervention Name(s)
FMRI with sham controlled feedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
FMRI with real time feedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Oxygen Level Dependent (BOLD) signal change during the active > passive contrast during the localizer session
Description
Using standard pre-processing pipelines, the general linear model, convolved with the hemodynamic response function, will be used to predict change in BOLD signal for the contrast of the active compared to the passive conditions. Z-transformed t-statistics will be corrected for multiple comparisons in the region of interest (salience network)
Time Frame
Approximately 40 minutes (during MRI)
Title
BOLD signal change during the active>passive contrast, comparing baseline with transfer runs (no NF in either), during the real time functional magnetic resonance imaging neurofeedback (rtfMRI-NF) session
Description
Same processing as outcome measure 2, except the contrast of active>passive will itself be contrasted within the session (baseline compared to transfer run)
Time Frame
Approximately 40 minutes (during MRI)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets The Diagnostic and Statistical Manual of Mental Disorders five (DSM5) criteria for Major Depressive Disorder, single or recurrent, active or in partial remission Patient Health Questionnaire (PHQ9) greater or equal (≥)6, and approximately (~) 50% with PHQ9≥10 If participants are taking antidepressant medications, on stable dosage for 4 weeks No history of active substance use disorder in the past 6 months Absence of suicidal thoughts with plans or intentions, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) If a woman of child-bearing age, not pregnant or trying to become pregnant 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, e. g. aneurysm clips, retained particles (for example metal workers with exposures, protocol has more details), etc. Size compatible with scanner gantry (per protocol) Ability and willingness to give informed consent to participate. Exclusion Criteria: Size not compatible with scanner Not meeting diagnostic criteria for bipolar disorder, schizophrenia, other psychosis, obsessive-compulsive disorder, active eating disorder or Post-traumatic stress disorder (PTSD) 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, e. g. loss of consciousness > ~5 min, hospitalization, neurological sequela
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophia Hovakimian
Phone
734-232-0129
Email
shovakim@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Stchur, MSW
Phone
734-936-1323
Email
lmarine@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Taylor, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophia Hovakimian
Phone
734-232-0129
Email
shovakim@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Laura Stchur, MSW
Phone
734-936-1323
Email
lmarine@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Stephan Taylor, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs