Language Network Prehab Via fMRI Neurofeedback

NCT07488780 | Not Yet Recruiting FDA Device

• 1 other identifier: 2000041907
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

fMRI

Outcome Measures

Primary Outcomes (4)

• Number of participants enrolled to assess feasibility

  Number of participants enrolled out of all screened

  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

  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

  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.

  Post surgery at 10 days

Study Arms (1)

fMRI neurofeedback (NF) and Glioma

EXPERIMENTAL

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

Interventions

fMRI DEVICE

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

fMRI neurofeedback (NF) and Glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Luca Pasquini, MD, PhD

  Yale School of Medicin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Pasquini, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study population consists of adult patients diagnosed with WHO grade II-III gliomas involving language-relevant cortical regions who are scheduled for surgical resection. Participants will receive epeated within-subject assessments.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)