NCT07488780 · Yale University
Language Network Prehab Via fMRI Neurofeedback
What this study is about
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.
View original scientific description
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.
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 enrolled out of all screened
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
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Haven, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2026 · Source of record for eligibility and locations