fMRI Neurofeedback for Brain Tumor

LP
Overseen ByLuca Pasquini, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fMRI neurofeedback, a brain imaging technique, can shift language functions away from areas affected by a glioma before surgery. Participants will undergo neuroimaging sessions to determine if the technique can improve language skills by engaging different brain regions. This presurgical strategy aims to make surgery safer and more effective. Individuals diagnosed with a WHO grade II-III glioma in the brain's language areas and planning surgery might be suitable for this study. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that this fMRI neurofeedback technique is safe for brain tumor patients?

Research has shown that fMRI neurofeedback is generally safe and well-tolerated by patients. One study on depression found a similar fMRI neurofeedback system effective without major side effects. Another study involving individuals with movement disorders reported that participants managed the treatment well, experiencing no significant negative effects.

fMRI, a common method for observing brain activity by tracking blood flow, is considered non-invasive, meaning it doesn't involve surgery or entering the body. Overall, available research suggests that fMRI neurofeedback is safe for participants, with minimal risk of serious side effects.12345

Why are researchers excited about this trial?

Unlike standard treatments for brain tumors that often focus on surgery, radiation, or chemotherapy, fMRI neurofeedback (NF) offers a unique approach by harnessing real-time brain imaging to enhance brain function before surgery. This technique specifically targets the eloquent language cortex, aiming to improve patients' cognitive outcomes by training their brains in a way that traditional methods do not. Researchers are excited about this trial because it could lead to a non-invasive, personalized way to prepare the brain for surgery, potentially improving recovery and preserving critical language functions.

What evidence suggests that fMRI neurofeedback is effective for brain tumors?

Research has shown that fMRI neurofeedback can help the brain redirect activity away from areas affected by glioma, a type of brain tumor. Studies have found that this technique can improve brain function and behavior, although more research is needed to fully understand it. In this trial, all participants will receive an fMRI neurofeedback intervention as a presurgical prehabilitation strategy. fMRI neurofeedback has successfully changed how different parts of the brain connect, potentially improving skills like language and focus. Additionally, fMRI techniques have enhanced recovery after brain tumor surgeries, leading to fewer issues with language and movement. These findings suggest that fMRI neurofeedback may be a promising tool for managing the effects of brain tumors.13567

Who Is on the Research Team?

MH

Michelle Hampson, PhD

Principal Investigator

Yale University

LP

Luca Pasquini, MD, PhD

Principal Investigator

Yale School of Medicin

Are You a Good Fit for This Trial?

This trial is for adults with a grade II-III glioma (a type of brain tumor) in areas important for language, who live within 2 hours of Yale, can undergo MRI scans, are scheduled for brain surgery, and can perform simple language tasks. People with severe speech problems or certain health issues can't join.

Inclusion Criteria

I have a grade II or III glioma affecting the language area of my brain.
I live within 2 hours of Yale and can attend multiple study visits.
MRI-compatible
See 4 more

Exclusion Criteria

Severe baseline aphasia precluding task performance
Contraindications to MRI
Significant cognitive/psychiatric comorbidity limiting compliance
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 6 months

Preoperative Intervention

Participants receive fMRI neurofeedback intervention as a prehabilitation strategy involving eloquent language cortex

7-10 days
Repeated within-subject assessments

Follow-up

Participants are monitored for safety and effectiveness after the intervention

10 days
Post-intervention neuropsychological testing and task-based fMRI measures

What Are the Treatments Tested in This Trial?

Interventions

  • fMRI

Trial Overview

The study tests if fMRI neurofeedback before surgery can help shift language function away from the tumor area. Participants will have multiple MRI sessions to train their brains using real-time feedback.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: fMRI neurofeedback (NF) and GliomaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Citations

A real-time fMRI neurofeedback system for the clinical ... - PMC

The objective of this study was to create a subject-independent brain state classifier as part of a real-time fMRI neurofeedback (rt-fMRI NF) system that can ...

fMRI Neurofeedback for Brain Tumor · Info for Participants

This is an interventional neuroimaging study that will examine whether fMRI neurofeedback can shift language network activity away from ...

Neurofeedback with fMRI: A critical systematic review

Neurofeedback relying on functional magnetic resonance imaging (fMRI-nf) heralds new prospects for self-regulating brain and behavior.

Identifying brain targets for real-time fMRI neurofeedback in ...

The efficacy of real-time functional magnetic resonance imaging neurofeedback for psychiatric illness: a meta-analysis of brain and behavioral outcomes.

Efficacy of Real Time Functional Magnetic Resonance ... - DTIC

There is a growing interest in the application of real-time (fMRI) with neurofeedback training. (NFT) to the treatment of disorders associated with abnormal ...

Functional Magnetic Resonance Imaging (fMRI) Neurofeedback

Physiological self-regulation of regional brain activity using real-time functional magnetic resonance imaging (fMRI): methodology and exemplary data.

Investigation of Neurofeedback With Real-Time fMRI in ...

The objective of this study is to see if healthy volunteers and patients with hyperkinetic movement disorders such as Tic Disorders (TD) including Tourette ...