Clinical trial NCT02879682: nTMS for Motor Mapping of Rolandic Lesions
Official title: Randomized Controlled Multicenter Trial on the Impact of Presurgical Navigated Transcranial Magnetic Stimulation for Motor Mapping of Rolandic Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Glioma
Brain Metastases
Keywords: glioma
brain metastases
nTMS
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Evangelisches Krankenhaus Bielefeld gGmbH
First posted: 2016-08-26
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: preoperative Mapping
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale
timeFrame: 3 months after surgery
Secondary outcomes:
measure: changed indication for surgery
timeFrame: 1 - 7 days before surgery
measure: change of the approach
timeFrame: 1 - 7 days before surgery
measure: size of craniotomy
timeFrame: intraoperatively
measure: use of intraoperative motor mapping via MEP
timeFrame: intraoperatively
measure: duration of intraoperative motor mapping via MEP
timeFrame: intraoperatively
measure: duration of surgery
timeFrame: intraoperatively
measure: extent of resection
timeFrame: intraoperatively
measure: use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal)
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Neurosurgery, Klinikum rechts der Isar, TUM
state: Bavaria
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum Neu-Kölln
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld
city: Günzburg
country: Germany
facility: Klinikum Günzburg
city: Messina
country: Italy
facility: Department of Neurosurgery, University of Messina
city: Bern
country: Switzerland
facility: Universität Bern
Study officials:
affiliation: Technical University of Munich
name: Sandro M Krieg, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: