Comparison of two stimulation methods for measuring movement potentials during the surgical removal of brain tumors regarding the prognostic accuracy of paralysis after surgery (TRANSEKT study)
Zusammenfassung der Studie
During surgeries for tumors within the skull. These tumors are located in an area of the brain that controls, among other things, the movement of certain body parts (hand, arm, leg, or foot). Therefore, monitoring of motor functions during the operation is necessary to remove the tumor as much as possible without impairing motor function. Since the operation is performed under general anesthesia, the movement function is monitored. The brain surface is electrically stimulated, and the response of the muscles of the arms/hands and/or legs/feet is measured and recorded. A deterioration of this response during tumor removal may indicate paralysis after surgery. This allows the surgeon to react and modify the surgical strategy.
(BASEC)
Untersuchte Intervention
Transcranial stimulation (through the skull bone): This is done using electrodes that are fixed on the scalp at specific points.
Direct cortical stimulation (directly on the brain): This is done using strip electrodes that are slid under the dura mater after the skull is opened and rest directly on the brain surface.
Both methods are established and are routinely used in our clinic. We aim to compare the two methods in this study regarding the rate of failures after surgery and the extent of tumor removal.
Study participants fill out a quality of life questionnaire. Additionally, a follow-up examination is conducted after 3 months.
(BASEC)
Untersuchte Krankheit(en)
Brain tumor
(BASEC)
- Planned surgical treatment of a brain tumor - Age between 18 and 80 years - Magnetic resonance imaging (MRI) to confirm that the tumor is near the movement center - Movement disorders - Patient is able to understand the meaning and significance of the clinical study in the context of patient information - Both stimulation methods are applicable (BASEC)
Ausschlusskriterien
- severe movement restrictions (paralysis) (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
Inselspital, University Hospital Bern
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Kathleen Seidel
+41 31 632 24 09
kathleen.seidel@clutterinsel.chDepartment of Neurosurgery
(BASEC)
Allgemeine Auskünfte
Universittsmedizin Gttingen
0551-39-65246
tammam.abboud@med.uni-goettingen.de(ICTRP)
Wissenschaftliche Auskünfte
Universitätsmedizin Göttingen
0551-39-65246
tammam.abboud@med.uni-goettingen.de(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.03.2022
(BASEC)
ICTRP Studien-ID
DRKS00023256 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Comparison between transcranial and direct cortical stimulation of motor evoked potentials during the resection of supratentorial brain tumors in terms of prognostic accuracy for postoperative motor deficits: A multicenter parallel-group randomized study (BASEC)
Wissenschaftlicher Titel
Transcranial versus Direct Cortical Stimulation for Motor Evoked Potentials during Resection of Supratentorial Tumors under General Anesthesia (the TRANSEKT-Trial), a Randomized Controlled Study - TRANSEKT (ICTRP)
Öffentlicher Titel
Transcranial versus Direct Cortical Stimulation for Motor Evoked Potentials during Resection of Supratentorial Tumors under General Anesthesia (the TRANSEKT-Trial), a Randomized Controlled Study (ICTRP)
Untersuchte Krankheit(en)
C71.0
C71.1
C71.2
C71.3Malignant neoplasm: Cerebrum, except lobes and ventriclesMalignant neoplasm: Frontal lobeMalignant neoplasm: Temporal lobeMalignant neoplasm: Parietal lobe (ICTRP)
Untersuchte Intervention
Group 1: Resection of a supratentorial tumor under transcranial electrical stimulation for monitoring of motor evoked potentials
Group 2: Resection of a supratentorial tumor under direct cortical stimulation for monitoring of motor evoked potentials. (ICTRP)
Studientyp
interventional (ICTRP)
Studiendesign
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: other (ICTRP)
Ein-/Ausschlusskriterien
Inclusion criteria: 1- Indication for surgical resection of a supratentorial tumor.
2- Suspected supratentorial glioma or metastasis in close vicinity to the corticospinal tract without Infiltration of the precentral gyrus, confirmed in a preoperative magnetic resonance imaging.
3- Missing or mild preoperative paresis (MRC grades 5 or 4)
4- Age => 18 and =< 80 years
5- Ability to give informed consent. (ICTRP)
Exclusion criteria: 1- Age < 18 or > 80 years
2- Preoperative MRI is not available
3- Severe preoperative paralysis (MRC grades 1,2 or 3)
4- One of the stimulation modalities is not appropriate for intraoperative application according to the neurosurgeon.
Primäre und sekundäre Endpunkte
Sensitivity and specificity of direct cortical and transcranial stimulation, in terms of predicting motor findings upon discharge or 7 days after surgery. (ICTRP)
1-Extent of tumor resection.
2-Clinical motor status 24 hours after surgery, on discharge (or 7 days after surgery) and after 3 months.
3-Barthel Index and Karnofsky performance Score, on discharge and after 3 months.
4-Self reported quality of life (EORTC QOL C30) and depressiveness (BDI-V) 3 months after surgery. (ICTRP)
Registrierungsdatum
29.10.2020 (ICTRP)
Einschluss des ersten Teilnehmers
03.12.2020 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Tammam Abboud, tammam.abboud@med.uni-goettingen.de, 0551-39-65246, Universittsmedizin Gttingen (ICTRP)
Sekundäre IDs
41/8/20 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
YesAfter the publication of the primary results, all data will be anonymised and published in an Open-Access-Repository. (ICTRP)
Weitere Informationen zur Studie
http://drks.de/search/en/trial/DRKS00023256 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar