Recruiting

fMRI Neurofeedback

Sponsor:

Yale University

Code:

NCT07488780

Conditions

Glioma

Glioma Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

fMRI

Study Details

Brief 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.

Conditions

Glioma

Glioma Surgery

Study ID

NCT07488780

Start date

Aug 1, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: fMRI neurofeedback (NF) and Glioma

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.

Interventions

fMRI

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Luca Pasquini, MD, PhD

203-688-2433luca.pasquini@yale.edu

Locations

Yale School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • fMRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Yale University on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.