Abstract
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.
Highlights
IntroductionCancer of the central nervous system, with glioma being its most common histological type, was responsible for 721,787 disability adjusted life years (DALYs) in western Europe creativecommons.org/licenses/by/ 4.0/)
Because neither the impact of the stimulation modalities nor that of the alarm criteria on postoperative motor function and extent of tumor resection has been investigated yet, we designed the TRANSEKT trial: a multicenter randomized double blind controlled exploratory study which will compare transcranial electrical stimulation (TES)-MEP with direct cortical stimulation (DCS)-MEP for monitoring of MEP in patients undergoing resection of brain tumor under general anesthesia. The aim of this first study is to calculate the required number of patients in a confirmatory trial to test the superiority of one method over the other
Self-reported quality of life using EORTC QOL C30 and BDI-S will enable us to gain concrete information about the effect of deterioration of motor function on the patient’s quality of life and their emotional health. These questionnaires have been validated in numerous papers addressing quality of life in cancer patients [27,28,29,30,31]. This trial was designed as an exploratory study to investigate sensitivity and specificity of TES and DCS in predicting postoperative motor deficits and study the influence of stimulation modality on the extent of tumor resection
Summary
Cancer of the central nervous system, with glioma being its most common histological type, was responsible for 721,787 disability adjusted life years (DALYs) in western Europe creativecommons.org/licenses/by/ 4.0/). The goal is to achieve maximum tumor resection. This should be performed without or with only minimal postoperative neurological deficits in order to avoid relevant impairment of the quality of life of the patients after the operation, which can affect their ability to receive adjuvant therapy. There is no guideline that favor one method over the other. We designed this randomized study to compare between both methods regarding the prediction of postoperative motor deficits and extent of tumor resection
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