Yale School of Medicine
New Haven, Connecticut, 06520, United States
NCT Number: NCT07488780
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06520, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Real-time functional magnetic resonance imaging (fMRI) neurofeedback (NF)
Time frame: up to 6 months
Number of participants enrolled out of all screened
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
Time frame: From initial neurosurgical evaluation to scheduled tumor resection, 7-10 days
Number of device-related adverse events
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.
Contact information is provided by the study sponsor or research team.
Yale University
Other
fMRI Neurofeedback for Prehabilitation of the Language Network in Patients Undergoing Radical Glioma Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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