Language Network Prehab Via fMRI Neurofeedback

March 17, 2026 updated by: Yale University

fMRI Neurofeedback for Prehabilitation of the Language Network in Patients Undergoing Radical Glioma Surgery

This is an interventional neuroimaging study that will examine whether fMRI neurofeedback can shift language network activity away from regions affected by glioma prior to surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to establish the feasibility and acceptability of implementing a brief, device-based fMRI neurofeedback (NF) intervention during the standard presurgical window in patients with WHO grade II-III gliomas involving eloquent language cortex.

The secondary objectives of this study are to obtain preliminary mechanistic and behavioral data regarding the effects of fMRI NF-based prehabilitation on language network organization and language performance. These secondary objectives are exploratory and intended to inform the design of a future randomized clinical trial.

The intervention will be conducted during the standard preoperative window and will not alter or delay clinical care. All participants will receive the same neurofeedback intervention as the primary goal of this study is to establish feasibility and generate pilot data. The study involves repeated within-subject assessments, including baseline and post-intervention neuropsychological testing and task-based fMRI measures, allowing each participant to serve as their own reference point for exploratory analyses.

Study Type

Interventional

Enrollment (Estimated)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Diagnosis of WHO grade II-III glioma involving eloquent language cortex
  • Scheduled for surgical resection
  • MRI-compatible
  • Ability to perform the simple language tasks required for fMRI and neurofeedback
  • Residence within 2 hours of Yale MRRC and ability and willingness to make multiple visits for study participation

Exclusion Criteria:

  • Severe baseline aphasia precluding task performance
  • Contraindications to MRI
  • Significant cognitive/psychiatric comorbidity limiting compliance
  • Concurrent enrollment in other interventional trials
  • Claustrophobia of a degree that they cannot comfortably be scanned
  • Inability or unwillingness to understand or follow the instructions
  • Pregnancy or possible pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fMRI neurofeedback (NF) and Glioma
All participants will receive an fMRI NF intervention delivered as a presurgical prehabilitation strategy involving eloquent language cortex. The intervention will be conducted during the standard preoperative window and will not alter or delay clinical care. The study involves repeated within-subject assessments, including baseline and post-intervention neuropsychological testing and task-based fMRI measures.
Device: fMRI
Real-time functional magnetic resonance imaging (fMRI) neurofeedback (NF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants enrolled to assess feasibility
Time Frame: up to 6 months
Number of participants enrolled out of all screened
up to 6 months
Number of participants completing all study visits to assess feasibility
Time Frame: From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
Number of participants completing all study visits within the standard presurgical window
From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
Number of device-related adverse events to assess safety
Time Frame: From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
Number of device-related adverse events
From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
Mean score Patient Experience Questionnaire (PEQ) to assess acceptability
Time Frame: Post surgery at 10 days
Participant-reported acceptability and perceived burden as measured by the Patient Experience Questionnaire (PEQ). Total score range 1-5 with higher scores indicating better experiences.
Post surgery at 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Luca Pasquini, MD, PhD, Yale School of Medicin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000041907

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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