Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area
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|ClinicalTrials.gov Identifier: NCT01351337|
Recruitment Status : Completed
First Posted : May 10, 2011
Results First Posted : April 20, 2015
Last Update Posted : April 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Glioma, Motor Pathway||Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Efficiency of Motor Pathway Mapping Using Diffusion Tensor Imaging Tractography and Intraoperative Subcortical Stimulation in Cerebral Glioma Surgery|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||February 2013|
intraoperative functional monitoring
intraoperative functional monitoring
Procedure: diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation
All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation
- Extent of Tumor Resection [ Time Frame: 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.
- Postoperative Motor Function and Long-time Functional Status [ Time Frame: 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.
- The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results [ Time Frame: 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351337
|Hushan Hospital, Fudan University|
|Shanghai, Shanghai, China, 200000|
|Study Chair:||Liangfu Zhou, Doctorate||Huashan Hospital|