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

Please always quote using this URN: urn:nbn:de:bvb:20-opus-248513
  • 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),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.show moreshow less

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Metadaten
Author: Tammam Abboud, Thomas Asendorf, Jutta Heinrich, Katharina Faust, Sandro M. Krieg, Kathleen Seidel, Dorothee Mielke, Cordola Matthies, Florian Ringel, Veit Rohde, Andrea Szelényi
URN:urn:nbn:de:bvb:20-opus-248513
Document Type:Journal article
Faculties:Medizinische Fakultät / Neurochirurgische Klinik und Poliklinik
Language:English
Parent Title (English):Biomedicines
ISSN:2227-9059
Year of Completion:2021
Volume:9
Issue:10
Article Number:1490
Source:Biomedicines (2021) 9:10, 1490. https://doi.org/10.3390/biomedicines9101490
DOI:https://doi.org/10.3390/biomedicines9101490
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Tag:amplitude criterion; direct cortical stimulation; intraoperative monitoring; threshold criterion; threshold level; transcranial motor-evoked potentials
Release Date:2022/11/17
Date of first Publication:2021/10/16
Licence (German):License LogoCC BY: Creative-Commons-Lizenz: Namensnennung 4.0 International