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NCT Number: NCT07488780

Language Network Prehab Via fMRI Neurofeedback

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fMRI

Device

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

Primary outcomes

  1. Number of participants enrolled to assess feasibility

    Time frame: up to 6 months

    Number of participants enrolled out of all screened

  2. 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

  3. 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

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Pasquini, MD, PhD

CONTACT

[email protected]

203-688-2433

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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