fMRI Neurofeedback for Prehabilitation of the Language Network in Patients Undergoing Radical Glioma Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of participants enrolled to assess feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: fMRI (Device)
结局指标
主要结局
Number of participants enrolled to assess feasibility
时间窗: up to 6 months
Number of participants enrolled out of all screened
Number of participants completing all study visits to assess feasibility
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点