此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Movie-Watching Functional MRI for Mapping Brain Function in Neurosurgical Patients

2026年6月17日 更新者:Yanmei, Tie、Brigham and Women's Hospital

Naturalistic Neuroimaging for Neurosurgical Brain Mapping

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.

研究概览

研究类型

介入性

注册 (估计的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital
        • 接触:
        • 接触:
        • 首席研究员:
          • Yanmei Tie, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:FMRI and Neuropsychological Assessments
Functional magnetic resonance imaging (fMRI) is a type of non-invasive imaging that measures blood oxygen level-dependent (BOLD) signal changes in the brain when a task is performed (such as reading) or BOLD signal changes during resting or watching naturalistic stimuli (such as movie clips).
其他名称:
  • 功能磁共振成像
Neuropsychological assessments are standardized tests used to evaluate cognitive, behavioral, and emotional functions that reflect the performance of different brain systems. These tests can be on paper or on a computer.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Language localization
大体时间: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).
From enrollment to up to 6 months after brain surgery.
Language lateralization
大体时间: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).
From enrollment to up to 6 months after brain surgery.
FMRI language activations concordance with language fiber tracts
大体时间: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.
From enrollment to up to 6 months after brain surgery.

次要结果测量

结果测量
措施说明
大体时间
Quality metrics based on electrocortical stimulation (ECS)
大体时间:From enrollment to up to 6 months after brain surgery.
Sensitivity and specificity computed relative to ECS positive/negative areas.
From enrollment to up to 6 months after brain surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Yanmei Tie, PhD、Brigham and Women's Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2029年3月31日

研究完成 (估计的)

2029年3月31日

研究注册日期

首次提交

2026年6月11日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅