期刊
BIOMEDICINES
卷 9, 期 10, 页码 -出版社
MDPI
DOI: 10.3390/biomedicines9101490
关键词
threshold criterion; amplitude criterion; intraoperative monitoring; transcranial motor-evoked potentials; direct cortical stimulation; threshold level
资金
- University Medical center, University of Goettingen
This study aims to compare transcranial electrical stimulation (TES) and direct cortical stimulation (DCS) in predicting postoperative motor deficits and extent of tumor resection, in order to determine the necessity for a larger confirmatory trial. The study plans to enroll 120 patients within two years, with the primary endpoint being assessment of postoperative motor function at 7 days, and the main secondary endpoint being the extent of tumor resection.
Background: Monitoring of motor function during surgery for supratentorial tumors under general anesthesia applies either transcranial electrical stimulation (TES) or direct cortical stimulation (DCS) to elicit motor-evoked potentials. To date, there is no guideline that favor one method over the other. Therefore, we designed this randomized study to compare between both methods regarding the prediction of postoperative motor deficits and extent of tumor resection. Methods: This is a multicenter (six centers in Germany and one in Switzerland), double blind, parallel group, exploratory, randomized controlled clinical trial. Patients without or with mild paresis, who are scheduled for surgical resection of motor-eloquent brain tumors under general anesthesia will be randomized to surgical resection under TES or surgical resection under DCS. The primary endpoint is sensitivity and specificity in prognosis of motor function 7 days after surgery. The main secondary endpoint is the extent of tumor resection. The study is planned to include 120 patients within 2 years. Discussion: The present exploratory study should compare TES and DCS regarding sensitivity and specificity in predicting postoperative motor deficit and extent of tumor resection to calculate the required number of patients in a confirmatory trial to test the superiority of one method over the other.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据