Transcranial versus Direct Cortical Stimulation for Motor-Evoked Potentials during Resection of Supratentorial Tumors under General Anesthesia (The TRANSEKT-Trial): Study Protocol for a Randomized Controlled Trial

被引:7
作者
Abboud, Tammam [1 ]
Asendorf, Thomas [2 ]
Heinrich, Jutta [3 ]
Faust, Katharina [4 ]
Krieg, Sandro M. [5 ]
Seidel, Kathleen [6 ]
Mielke, Dorothee [1 ]
Matthies, Cordola [7 ]
Ringel, Florian [8 ]
Rohde, Veit [1 ]
Szelenyi, Andrea [9 ]
机构
[1] Univ Med Ctr Gottingen, Dept Neurosurg, Robert Koch Str 40, D-37075 Gottingen, Germany
[2] Univ Med Ctr Gottingen, Dept Med Stat, Humboldtallee 32, D-37073 Gottingen, Germany
[3] Univ Med Ctr Gottingen, Clin Trial Unit, Robert Koch Str 40, D-37075 Gottingen, Germany
[4] Charite Univ Clin, Dept Neurosurg, D-10117 Berlin, Germany
[5] Tech Univ, Dept Neurosurg, Klinikum Rechts Isar, Sch Med, D-81675 Munich, Germany
[6] Univ Hosp, Dept Neurosurg, Inselspital, CH-3010 Bern, Switzerland
[7] Univ Med Ctr Wurzburg, Dept Neurosurg, D-97080 Wurzburg, Germany
[8] Univ Med Ctr Mainz, Dept Neurosurg, D-55131 Mainz, Germany
[9] Ludwig Maximilians Univ Munchen, Dept Neurosurg, Campus Grosshadern, D-81377 Munich, Germany
关键词
threshold criterion; amplitude criterion; intraoperative monitoring; transcranial motor-evoked potentials; direct cortical stimulation; threshold level; QUALITY-OF-LIFE; INTRAVENOUS IMMUNE GLOBULIN; CORTICOSPINAL TRACT; BRAIN-TUMORS; SURGERY; METASTASES; EXTENT;
D O I
10.3390/biomedicines9101490
中图分类号
Q5 [生物化学]; Q7 [分子生物学];
学科分类号
071010 ; 081704 ;
摘要
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.
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页数:11
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