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Behavioural Intervention

fMRI Neurofeedback for Depression

N/A

Waitlist Available

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 40 minutes (during mri)

Awards & highlights

Study Summary

This trial is developing a technique to help people better regulate their brain activity to manage psychiatric symptoms. #RealTimefMRINeurofeedback

Who is the study for?

This trial is for individuals with depression or healthy subjects willing to give informed consent. Participants should not be on any psychotropic medications, except birth control. Women must not be pregnant or trying to conceive. Candidates must have no serious neurological illnesses, tolerate enclosed spaces without anxiety, and have no metal implants that could react in an MRI.Check my eligibility

What is being tested?

The study is testing a technique called real-time fMRI neurofeedback which provides immediate feedback on brain activity while participants are in the scanner. The aim is to help people regulate their brain activity which may assist in managing symptoms of depression.See study design

What are the potential side effects?

There are typically no direct side effects from undergoing an fMRI scan itself; however, some individuals might experience discomfort due to lying still for long periods or anxiety from being in the confined space of the MRI machine.

Eligibility Criteria

Inclusion Criteria

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

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I am not on any medication with mind-altering effects, except for birth control.

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I am not pregnant nor trying to conceive.

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I have no serious brain-related health issues or conditions like liver failure that could affect my brain.

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 Focus>Rest contrast, comparing baseline with transfer runs (no NF in either), during the rtfMRI-NF session

Blood Oxygen Level Dependent (BOLD) signal change during the Focus greater (>) Rest contrast during the localizer session

Secondary outcome measures

Neurofeedback signal (moving window for each stop>recall trial pair) during the rtfMRI-NF session

Side effects data

From 2022 Phase 2 trial • 182 Patients • NCT02966873

19%

Gastrointestinal Discomfort

16%

Viral Upper Respiratory Tract Infections (Cold)

10%

Nausea

10%

Injury

Muscle or Joint Pain

Flatulence

Headache/Migraine

Sinusitis

Pneumonia

Anxiety

Constipation

Stroke

Sepsis

Pancreatitis

Bladder Infection

Injury/Accident

100%

80%

60%

40%

20%

Study treatment Arm

N-Acetylcysteine (NAC) Treatment Group

Placebo Group

Trial Design

1Treatment groups

Experimental Treatment

Group I: Magnetic resonance imaging (MRI) groupExperimental Treatment1 Intervention

Healthy volunteers will have two functional magnetic resonance imaging scans (localizer session and the real time functional magnetic resonance imaging neurofeedback session).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,130 Total Patients Enrolled

Stephan Taylor, MDPrincipal InvestigatorUniversity of Michigan

4 Previous Clinical Trials

359 Total Patients Enrolled

Media Library

Functional Magnetic Resonance Imaging (fMRI) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05934604 — N/A

Healthy Subjects Research Study Groups: Magnetic resonance imaging (MRI) group

Healthy Subjects Clinical Trial 2023: Functional Magnetic Resonance Imaging (fMRI) Highlights & Side Effects. Trial Name: NCT05934604 — N/A

Functional Magnetic Resonance Imaging (fMRI) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05934604 — N/A

Frequently Asked Questions

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

Is there a cutoff age for participants in this research?

"The eligibility requirements for this clinical trial stipulate that patients must be aged 18 to 55 in order to participate."

Answered by AI

Is this experiment open to volunteers?

"To qualify for enrollment, prospective participants must be in good health and aged 18-55. The overall sample size of the study is 12 individuals."

Answered by AI

Are recruitment efforts currently underway for this medical trial?

"The information on clinicaltrials.gov illustrates that this trial is not currently enrolling candidates. It was first posted on 9/1/2023 and the latest update occurred on 6/28/2023. However, there are 1972 other medical studies actively recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Stephan F. Taylor 2023. "Targeting Large-scale Networks in Depression With Real-time fMRI (Functional Magnetic Resonance Imaging) Neurofeedback". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05934604.