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Behavioural Intervention

fMRI Neurofeedback for Depression

N/A

Recruiting

Led By Stephan Taylor, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 40 minutes (during mri)

Awards & highlights

Study Summary

This trial seeks to develop a technique to help people regulate brain activity, through feedback during an fMRI scan, to manage psychiatric symptoms.

Who is the study for?

This trial is for adults with Major Depressive Disorder who are not pregnant, can handle small spaces without anxiety, have been on a stable antidepressant dose for 4 weeks, and don't have metal implants that affect MRI scans. They must also be of a size to fit in the scanner and willing to consent. Participants should not have serious neurological issues or certain psychiatric conditions like bipolar disorder.Check my eligibility

What is being tested?

The study tests real-time fMRI neurofeedback versus sham feedback to help manage depression by teaching participants to regulate brain activity. It's part of a larger project funded by the National Institutes of Health and follows an earlier phase (NCT05934604).See study design

What are the potential side effects?

Since this intervention involves non-invasive brain imaging rather than medication, typical drug side effects aren't expected. However, some individuals might experience discomfort from lying still in the MRI machine or anxiety due to being in an enclosed space.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not pregnant nor trying to conceive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 40 minutes (during mri)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 40 minutes (during mri)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 40 minutes (during mri) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Blood Oxygen Level Dependent (BOLD) signal change during the active > passive contrast during the localizer session

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Real-time neurofeedbackExperimental Treatment1 Intervention

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.

Group II: Sham controlled feedbackPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,639 Total Patients Enrolled

667 Trials studying Depression

251,584 Patients Enrolled for Depression

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,068 Total Patients Enrolled

68 Trials studying Depression

69,123 Patients Enrolled for Depression

Stephan Taylor, MDPrincipal InvestigatorUniversity of Michigan

4 Previous Clinical Trials

297 Total Patients Enrolled

2 Trials studying Depression

12 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do adults of at least twenty years qualify for participation in this trial?

"This medical research initiative is searching for participants aged between 18 to 55 years old."

Answered by AI

Who are the allowable participants in this medical experiment?

"This study is accepting participants aged 18 to 55 years old who have been diagnosed with depression. To date, 70 individuals are sought for this medical trial."

Answered by AI

Are new participants able to join this trial at the present time?

"According to clinicaltrials.gov, the posting of this trial which was initially made on December 1st 2023 is no longer actively recruiting patients. However, there are 877 other clinical trials that are currently looking for participants at this moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Stephan F. Taylor 2024. "Targeting Large-scale Networks in Depression With Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06050070.