What side effects are associated with this type of intervention?

The most common treatments similar to real-time fMRI neurofeedback include transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). For TMS, side effects are generally mild and may include headache, scalp discomfort, and, in rare cases, a generalized tonic-clonic seizure. tDCS side effects are also typically mild, including skin irritation at the electrode site, tingling, and mild headache. Both treatments are considered safe with no serious long-term adverse effects reported in the context provided.

What prior FDA approvals exist?

FDA-approved treatments similar to real-time fMRI neurofeedback include transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS). TMS, which uses magnetic fields to stimulate nerve cells in the brain, is approved for treating depression, particularly in patients who have not responded to other treatments. VNS, which involves electrical stimulation of the vagus nerve, is also approved for treatment-resistant depression. Both methods aim to modulate brain activity, similar to the goals of real-time fMRI neurofeedback.

What other types of research exist?

Promising, novel alternatives to Real-time fMRI Neurofeedback for regulating brain activity include Transcranial Magnetic Stimulation (TMS) and Transcutaneous Supraorbital Nerve Stimulation. TMS has shown efficacy in both acute treatment and prevention of migraines, and it is approved for use in adolescents and adults. Transcutaneous Supraorbital Nerve Stimulation has demonstrated benefits in reducing migraine days and is also approved for marketing in multiple countries.

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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 the second mri)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new technique called real-time fMRI neurofeedback. It uses a special brain scan to show participants their brain activity as it happens. The goal is to help people learn to control their brain activity, which could be useful for managing mental health conditions like depression. The study starts with healthy participants to refine the technique. Real-time fMRI neurofeedback has been used to help individuals learn to control their brain activity, with applications in treating various neurological and psychiatric conditions.

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.

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.

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 the second mri)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 40 minutes (during the second mri)

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Real-time fMRI neurofeedback involves using functional MRI to monitor brain activity in real-time and providing feedback to the individual to help them regulate this activity. This technique targets specific brain regions associated with various cognitive and emotional functions. By receiving immediate feedback, individuals can learn to modulate their brain activity, potentially improving self-regulation and mental health. For healthy subjects, this matters because it can enhance cognitive performance, emotional regulation, and overall mental well-being, offering a non-invasive method to optimize brain function.

Psychotherapy and neuroscience: towards closer integration.