Language Network Prehab Via fMRI Neurofeedback

Official title

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

Overview

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.

Interventions

• Device fMRI
  Real-time functional magnetic resonance imaging (fMRI) neurofeedback (NF)

Primary outcome measures

• Number of participants enrolled to assess feasibility [Time frame: 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 device-related adverse events to assess safety [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

United States · 1 center

• Yale School of Medicine — New Haven

Identifiers

NCT: NCT07488780 · 2000041907

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗