nTMS for Motor Mapping of Rolandic Lesions

Technical University of Munich330 enrolled

Overview

To compare presurgical motor mapping by navigated transcranial magnetic stimulation for surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data into neuronavigation as control. Primary objective: Permanently new postoperative deficit is lower when the preoperative motor mapping is available to the surgeon

Experimental intervention: presurgical motor mapping by navigated transcranial magnetic stimulation and fusion with intraoperative neuronavigation Control intervention: presurgical motor mapping by navigated transcranial magnetic stimulation without access of the surgeon to this data Follow-up per patient: 6 months Duration of intervention per patient: 45 minutes

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

330

Conditions

Glioma Brain Metastases

Interventions

nTMS data available for the surgeonPROCEDURE

the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon

nTMS data not available for the surgeonPROCEDURE

the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

Key inclusion criteria: * indication for resection of a supratentorial tumor within or adjacent to the primary motor cortex * preoperative nTMS mapping of the ipsilateral hemisphere * implementation of the mapping data into preoperative planning * continuous MEP monitoring - informed consent Key exclusion criteria: * no motor eloquent tumor * infratentorial tumor * no postoperative imaging * prognosis lower than 3 months of survival - age \<18 years

Locations (7)

Department of Neurosurgery, Klinikum rechts der Isar, TUM

Munich, Bavaria, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Vivantes Klinikum Neu-Kölln

Berlin, Germany

Klinikum Bielefeld

Bielefeld, Germany

Outcomes

Primary Outcomes

Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale

deterioration in NIHSS score

Time frame: 3 months after surgery

Secondary Outcomes

changed indication for surgery

towards surgery, avoids surgery towards biopsy, avoids surgery towards follow-up

Time frame: 1 - 7 days before surgery

change of the approach

using a different direct to approach the lesion (different sulcus, gyrus, sub cortically)

Time frame: 1 - 7 days before surgery

size of craniotomy

in mm ap and lateral

Time frame: intraoperatively

use of intraoperative motor mapping via MEP

yes/no

Time frame: intraoperatively

duration of intraoperative motor mapping via MEP

in min

Time frame: intraoperatively

duration of surgery

in min

Time frame: intraoperatively

extent of resection

in % via volumetry

Time frame: intraoperatively

use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal)

yes/no

Data from ClinicalTrials.gov

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