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)
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- severe movement restrictions (paralysis) (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
Inselspital, University Hospital Bern
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Kathleen Seidel
+41 31 632 24 09
kathleen.seidel@clutterinsel.chDepartment of Neurosurgery
(BASEC)
Informazioni generali
Universittsmedizin Gttingen
0551-39-65246
tammam.abboud@med.uni-goettingen.de(ICTRP)
Informazioni scientifiche
Universitätsmedizin Göttingen
0551-39-65246
tammam.abboud@med.uni-goettingen.de(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
09.03.2022
(BASEC)
ID di studio ICTRP
DRKS00023256 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
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)
Malattie studiate
C71.0
C71.1
C71.2
C71.3Malignant neoplasm: Cerebrum, except lobes and ventriclesMalignant neoplasm: Frontal lobeMalignant neoplasm: Temporal lobeMalignant neoplasm: Parietal lobe (ICTRP)
Intervento studiato
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)
Tipo di studio
interventional (ICTRP)
Disegno dello studio
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: other (ICTRP)
Criteri di inclusione/esclusione
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.
Endpoint primari e secondari
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)
Data di registrazione
29.10.2020 (ICTRP)
Inclusione del primo partecipante
03.12.2020 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Tammam Abboud, tammam.abboud@med.uni-goettingen.de, 0551-39-65246, Universittsmedizin Gttingen (ICTRP)
ID secondari
41/8/20 (ICTRP)
Risultati-Dati individuali dei partecipanti
YesAfter the publication of the primary results, all data will be anonymised and published in an Open-Access-Repository. (ICTRP)
Ulteriori informazioni sullo studio
http://drks.de/search/en/trial/DRKS00023256 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile