fMRI Neurofeedback for Glioma Surgery Preparation

This study is testing if real-time functional magnetic resonance imaging (fMRI) neurofeedback (NF) can help shift language activity in the brain away from areas affected by a glioma tumor before surgery. This intervention uses a device to provide feedback during fMRI scans. The study aims to see if this approach is practical and acceptable for patients with WHO grade II-III glioma (a type of brain tumor) that affects the language parts of the brain. You might be able to join if you are 18 or older, have this type of glioma, are scheduled for surgery, and can perform simple language tasks during fMRI. The study plans to enroll 4 participants to assess how feasible and safe this intervention is.

Study design
This is an interventional study with no specified phase, enrolling 4 participants. All participants will receive the same fMRI neurofeedback intervention.
What's involved
You would undergo neuropsychological testing and task-based fMRI measures before and after the intervention, which takes place during the standard preoperative window (7-10 days).
Compensation
Not stated in the trial record.
Follow-up
Safety and feasibility will be measured from initial neurosurgical evaluation to scheduled tumor resection, lasting 7-10 days, and up to 6 months for enrollment feasibility.

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NCT07488780

Language Network Prehab Via fMRI Neurofeedback

Not Yet Recruiting
NAAges 18+InterventionalDevice feasibility
Yale University
~4 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:fMRI

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants enrolled to assess feasibility
Measured over up to 6 months
+3 more outcomes measured
Glioma
Glioma Surgery
1 sites across 1 states
Connecticut1
  • Luca Pasquini, MD, PhD · PRINCIPAL_INVESTIGATOR · Yale School of Medicin
  • Michelle Hampson, PhD · PRINCIPAL_INVESTIGATOR · Yale University

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Eligibility criteria

Inclusion

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

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
  • Number of participants enrolled to assess feasibilityup to 6 months

    Number of participants enrolled out of all screened

  • Number of participants completing all study visits to assess feasibilityFrom initial neurosurgical evaluation to scheduled tumor resection, 7-10 days

    Number of participants completing all study visits within the standard presurgical window

  • Number of device-related adverse events to assess safetyFrom initial neurosurgical evaluation to scheduled tumor resection, 7-10 days

    Number of device-related adverse events

  • Mean score Patient Experience Questionnaire (PEQ) to assess acceptabilityPost 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.