TY  - JOUR
A1  - Abboud, Tammam
A1  - Asendorf, Thomas
A1  - Heinrich, Jutta
A1  - Faust, Katharina
A1  - Krieg, Sandro M.
A1  - Seidel, Kathleen
A1  - Mielke, Dorothee
A1  - Matthies, Cordola
A1  - Ringel, Florian
A1  - Rohde, Veit
A1  - Szelényi, Andrea
T1  - 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
JF  - Biomedicines
N2  - 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.
KW  - threshold criterion
KW  - amplitude criterion
KW  - intraoperative monitoring
KW  - transcranial motor-evoked potentials
KW  - direct cortical stimulation
KW  - threshold level
Y1  - 2021
U6  - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-248513
SN  - 2227-9059
VL  - 9
IS  - 10
ER  -