Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area
2015年4月4日 更新者：Jinsong Wu、Huashan Hospital
Clinical Efficiency of Motor Pathway Mapping Using Diffusion Tensor Imaging Tractography and Intraoperative Subcortical Stimulation in Cerebral Glioma Surgery
Resection of brain tumors in eloquent areas involves the risk of postoperative motor deficits.
For brain tumors within or adjacent to the eloquent area, maximizing tumor resection while preserving motor function is crucially important.we
used DTI-based tractography to visualize the spatial relationship between brain lesions and the nearby pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional connections of the illustrated PT by direct electrical stimulation.
We evaluated the reliability of DTI-based tractography for PT mapping using intraoperative subcortical stimulation ) and the usefulness of the combination of two techniques.
研究概览
地位
完全的
详细说明
Adverse effects caused by electrical stimulation during the operation were recorded.
All subjects adopted early postoperative MRI examinations (within 3 days) to evaluate both the extent of tumor resection and the integrity of the PTs.
Muscle strength was assessed preoperatively and postoperatively.The Karnofsky Performance Scale (KPS) was adopted for grading functional status at the 6-month evaluation.
Further tumor progression interval and survival analysis was conducted for each subject with high-grade glioma (HGG)
研究类型
介入性
注册 (实际的)
58
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。
学习地点
-
-
Shanghai
-
Shanghai、Shanghai、中国、200000
- Hushan Hospital, Fudan University
-
-
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
6年 至 75年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- patients with an initial imaging diagnosis of single, unilateral, supratentorial primary glioma (or intrinsic neoplasm).
- The lesions were involved in PTs, comprising cortical regions in the motor or somatosensory areas, cortical regions adjacent to the central gyrus, subcortical regions with an infiltrative progression along the PTs, and temporal or insular regions in relation to the internal capsule.
- MRI enabled preoperative identification of patients in whom maximal tumor resection was likely to be achieved, and close PT approach within resection cavity at the time of surgery was possible.
Exclusion Criteria:
- patients with secondary or recurrent gliomas (or intrinsic neoplasm), patients with contraindications for MRI or direct electrical stimulation, and patients in whom initial muscle strength grades of the affected extremities was 2/5 or lower.
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：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：intraoperative functional monitoring
|
All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation
|
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 |
|---|---|---|
|
Extent of Tumor Resection
大体时间：within 3 days
|
Volumetric analysis was performed both before and after surgery by calculating the tumor volume on the images of enhanced 3-D MP-RAGE sequence for high-grade gliomas and FLAIR sequence for low-grade gliomas.
The extent of tumor resection was the ratio of pre-op tumor volume over post-op tumor volume.
Gross total resection refers to a 100% resection of the tumor volume; near-total resection refers to 95% to 100% resection; subtotal resection refers to 90% to 95% resection; partial resection refers to 75% to 90% resection; and biopsy refers to ,75% resection of the tumor volume for histological diagnosis.
|
within 3 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Motor Function and Long-time Functional Status
大体时间：3 days to 6 months after surgery
|
Motor function was assessed early postoperatively (within 72 hours after the operation), and 1 month after discharge.
The muscle strength of each subject was graded for both the upper and lower extremities with the Medical Research Council Scale.
Grade 5: Muscle contracts against full resistance; Grade 4: Strength reduced, but contraction can still move joint against resistance; Grade 3: Strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed.
Grade 2: Muscle can onlly move if resistance of gravity is removed.
Grade 1: Only a trace or flicker of movement is seen or felt, or fasciculations are observed; Grade 0:No movement.
|
3 days to 6 months after surgery
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results
大体时间：During the operation
|
The sensitivity of DTI tractography for PT mapping was calculated as the ratio between the number of subjects with positive DsCS results in the positive DTI zone (true positive) and the total number of subjects with positive DsCS results (true positive plus false negative).
The specificity was measured as the ratio between the number of subjects with negative DsCS results in the negative DTI zone (true negative) and the total number of subjects with negative DsCS results (true negative plus false positive).
The accordance rate of DsCS and DTI was measured as the ratio between the number of subjects with either a true-positive or true-negative DsCS result and the total number of subjects.
|
During the operation
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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
- 学习椅：Liangfu Zhou, Doctorate、Huashan 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。
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
2008年10月1日
初级完成 (实际的)
2009年6月1日
研究完成 (实际的)
2013年2月1日
研究注册日期
首次提交
2011年5月9日
首先提交符合 QC 标准的
2011年5月9日
首次发布 (估计)
2011年5月10日
研究记录更新
最后更新发布 (估计)
2015年4月20日
上次提交的符合 QC 标准的更新
2015年4月4日
最后验证
2015年4月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 07QA14008 (其他赠款/资助编号：The govermment of Shanghai, China)
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.