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Article

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

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Department of Neurosurgery, University Medical Center Göttingen, Robert-Koch-Straße 40, 37075 Göttingen, Germany
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Department of Medical Statistics, University Medical Center Göttingen, Humboldtallee 32, 37073 Göttingen, Germany
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Clinical Trial Unit, University Medical Center Göttingen, Robert-Koch-Straße 40, 37075 Göttingen, Germany
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Department of Neurosurgery, Charité University Clinic, 10117 Berlin, Germany
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Department of Neurosurgery, Klinikum Rechts der Isar, School of Medicine, Technische Universität, 81675 München, Germany
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Department of Neurosurgery, Inselspital, University Hospital, 3010 Bern, Switzerland
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Department of Neurosurgery, University Medical Center Würzburg, 97080 Würzburg, Germany
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Department of Neurosurgery, University Medical Center Mainz, 55131 Mainz, Germany
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Department of Neurosurgery, Campus Grosshadern, Ludwig-Maximilians-University, 81377 Munich, Germany
*
Author to whom correspondence should be addressed.
Academic Editor: George Alexiou
Biomedicines 2021, 9(10), 1490; https://doi.org/10.3390/biomedicines9101490
Received: 23 September 2021 / Revised: 8 October 2021 / Accepted: 14 October 2021 / Published: 16 October 2021
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. View Full-Text
Keywords: threshold criterion; amplitude criterion; intraoperative monitoring; transcranial motor-evoked potentials; direct cortical stimulation; threshold level threshold criterion; amplitude criterion; intraoperative monitoring; transcranial motor-evoked potentials; direct cortical stimulation; threshold level
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MDPI and ACS Style

Abboud, T.; Asendorf, T.; Heinrich, J.; Faust, K.; Krieg, S.M.; Seidel, K.; Mielke, D.; Matthies, C.; Ringel, F.; Rohde, V.; Szelényi, A. 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. Biomedicines 2021, 9, 1490. https://doi.org/10.3390/biomedicines9101490

AMA Style

Abboud T, Asendorf T, Heinrich J, Faust K, Krieg SM, Seidel K, Mielke D, Matthies C, Ringel F, Rohde V, Szelényi A. 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. Biomedicines. 2021; 9(10):1490. https://doi.org/10.3390/biomedicines9101490

Chicago/Turabian Style

Abboud, Tammam, Thomas Asendorf, Jutta Heinrich, Katharina Faust, Sandro M. Krieg, Kathleen Seidel, Dorothee Mielke, Cordola Matthies, Florian Ringel, Veit Rohde, and Andrea Szelényi. 2021. "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" Biomedicines 9, no. 10: 1490. https://doi.org/10.3390/biomedicines9101490

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