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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fMRI | Device | Real-time functional magnetic resonance imaging (fMRI) neurofeedback (NF) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Pasquini, MD, PhD | Contact | 203-688-2433 | luca.pasquini@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Luca Pasquini, MD, PhD | Yale School of Medicin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |