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NCT07488780NARecruiting

Language Network Prehab Via fMRI Neurofeedback

Yale University

Start Date

8/1/2026

Completion Date

12/1/2026

Summary

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

fMRI

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Conditions

GliomaGlioma Surgery

Locations

Yale School of Medicine

New Haven, Connecticut 06520

United States