Language Network Prehab Via fMRI Neurofeedback
fMRI Neurofeedback for Prehabilitation of the Language Network in Patients Undergoing Radical Glioma Surgery
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luca Pasquini, MD, PhD
- Phone Number: 203-688-2433
- Email: luca.pasquini@yale.edu
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Real-time functional magnetic resonance imaging (fMRI) neurofeedback (NF)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants enrolled to assess feasibility
Time Frame: up to 6 months
|
Number of participants enrolled out of all screened
|
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 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
Time Frame: From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
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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
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.
|
Post surgery at 10 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michelle Hampson, PhD, Yale University
- Principal Investigator: Luca Pasquini, MD, PhD, Yale School of Medicin
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000041907
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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