An interventional study of fMRI in Glioma and Glioma Surgery, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Yale University · Not applicable, Interventional, and Device feasibility
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.
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.
Exclusion Criteria:
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)
Number of participants enrolled to assess feasibility
Number of participants enrolled out of all screened
Time frame: up to 6 months
Number of participants completing all study visits to assess feasibility
Number of participants completing all study visits within the standard presurgical window
Time frame: From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
Number of device-related adverse events to assess safety
Number of device-related adverse events
Time frame: From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
Mean score Patient Experience Questionnaire (PEQ) to assess acceptability
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.
Time frame: Post surgery at 10 days
Plan to share: No
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Yale University