Glioma, Glioma Surgery
Conditions
Keywords
fMRI
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.
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.
Interventions
DEVICEfMRI
Real-time functional magnetic resonance imaging (fMRI) neurofeedback (NF)
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants enrolled to assess feasibility | up to 6 months | Number of participants enrolled out of all screened |
| Number of participants completing all study visits to assess feasibility | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTLuca Pasquini, MD, PhD
PRINCIPAL_INVESTIGATORLuca Pasquini, MD, PhD
Yale School of Medicin
PRINCIPAL_INVESTIGATORMichelle Hampson, PhD
Yale University
Outcome results
None listed