Naturalistic Neuroimaging for Neurosurgical Brain Mapping
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Language localization
研究概览
简要总结
This research will compare a new type of functional MRI (fMRI) called naturalistic viewing (also called movie watching) to standard clinical fMRI techniques. Standard clinical fMRI currently uses multiple tasks such as reading and responding to words or sentences to determine which areas of the brain are responsible for language. Surgeons can use this information to help plan brain surgeries. This research will help determine if the movie-watching fMRI is equivalent or better than the standard task-based fMRI. If so, it could be useful for planning patients' surgeries in the future, without the need for multiple tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any sex, age between 21 to 70 years;
- •Known or suspected glioma (lesion) of the brain;
- •English speaking;
- •Patients with clinical fMRI scheduled (or pending scheduling) for presurgical planning at BWH ordered by a BWH clinician;
- •Passes prescreening and standard of care screenings for 3 Tesla MRI;
- •Willing to participate in the additional study scan and neuropsychological assessment visit;
- •Informed consent form signed by the subject or legally acceptable representative.
排除标准
- •Contraindications to MRI: Note: MRI screening will be performed by radiology staff as part of their standard process for their clinical scans and if subjects do not pass the screen, MRI will not be performed.
- •Pregnancy or possible pregnancy: Female participants under 55 (or 45 with menstrual cycle in the past 12 months) who may be pregnant. Per policy: potential subjects will be asked if they are pregnant and excluded if they say yes. If unsure, pregnancy testing will be performed. Any subjects with positive result will be excluded.
研究组 & 干预措施
FMRI and Neuropsychological Assessments
干预措施: Functional magnetic resonance imaging (fMRI) (Other)
FMRI and Neuropsychological Assessments
干预措施: Neuropsychological Assessments (Behavioral)
结局指标
主要结局
Language localization
时间窗: From enrollment to up to 6 months after brain surgery.
Sensitivity and specificity based on the proportion of activation within and outside of language regions-of-interest (ROIs).
Language lateralization
时间窗: From enrollment to up to 6 months after brain surgery.
Laterality index (LI) based on proportion of activation in the left vs. right hemisphere in language regions-of-interest (ROIs).
FMRI language activations concordance with language fiber tracts
时间窗: From enrollment to up to 6 months after brain surgery.
Concordance with language fiber tracts identified by diffusion MRI in terms of the Euclidean distance between fMRI language activations and the tracts.
次要结局
- Quality metrics based on electrocortical stimulation (ECS)(From enrollment to up to 6 months after brain surgery.)
研究者
Yanmei, Tie
Assistant Professor
Brigham and Women's Hospital