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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

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 ot...

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Autores principales: Abboud, Tammam, Asendorf, Thomas, Heinrich, Jutta, Faust, Katharina, Krieg, Sandro M., Seidel, Kathleen, Mielke, Dorothee, Matthies, Cordola, Ringel, Florian, Rohde, Veit, Szelényi, Andrea
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8533079/
https://www.ncbi.nlm.nih.gov/pubmed/34680607
http://dx.doi.org/10.3390/biomedicines9101490
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author Abboud, Tammam
Asendorf, Thomas
Heinrich, Jutta
Faust, Katharina
Krieg, Sandro M.
Seidel, Kathleen
Mielke, Dorothee
Matthies, Cordola
Ringel, Florian
Rohde, Veit
Szelényi, Andrea
author_facet Abboud, Tammam
Asendorf, Thomas
Heinrich, Jutta
Faust, Katharina
Krieg, Sandro M.
Seidel, Kathleen
Mielke, Dorothee
Matthies, Cordola
Ringel, Florian
Rohde, Veit
Szelényi, Andrea
author_sort Abboud, Tammam
collection PubMed
description 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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spelling pubmed-85330792021-10-23 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 Abboud, Tammam Asendorf, Thomas Heinrich, Jutta Faust, Katharina Krieg, Sandro M. Seidel, Kathleen Mielke, Dorothee Matthies, Cordola Ringel, Florian Rohde, Veit Szelényi, Andrea Biomedicines Article 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. MDPI 2021-10-16 /pmc/articles/PMC8533079/ /pubmed/34680607 http://dx.doi.org/10.3390/biomedicines9101490 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Abboud, Tammam
Asendorf, Thomas
Heinrich, Jutta
Faust, Katharina
Krieg, Sandro M.
Seidel, Kathleen
Mielke, Dorothee
Matthies, Cordola
Ringel, Florian
Rohde, Veit
Szelényi, Andrea
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8533079/
https://www.ncbi.nlm.nih.gov/pubmed/34680607
http://dx.doi.org/10.3390/biomedicines9101490
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