nTMS for Motor Mapping of Rolandic Lesions

Glioma Clinical Trial

— Motorstim  

Official title:

Randomized Controlled Multicenter Trial on the Impact of Presurgical Navigated Transcranial Magnetic Stimulation for Motor Mapping of Rolandic Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879682
• Other study ID #: 5496/12
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2016
• Est. completion date: April 2023

Study information

• Verified date: May 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: April 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Glioma
• Neoplasm Metastasis

Intervention

Procedure:
• nTMS data available for the surgeon
the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon
• nTMS data not available for the surgeon
the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Vivantes Klinikum Neu-Kölln	Berlin
Germany	Klinikum Bielefeld	Bielefeld
Germany	Klinikum Günzburg	Günzburg
Germany	Department of Neurosurgery, Klinikum rechts der Isar, TUM	Munich	Bavaria
Italy	Department of Neurosurgery, University of Messina	Messina
Switzerland	Universität Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
Technical University of Munich	Charite University, Berlin, Germany, Evangelisches Krankenhaus Bielefeld gGmbH

Countries where clinical trial is conducted

Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale	deterioration in NIHSS score	3 months after surgery
Secondary	changed indication for surgery	towards surgery, avoids surgery towards biopsy, avoids surgery towards follow-up	1 - 7 days before surgery
Secondary	change of the approach	using a different direct to approach the lesion (different sulcus, gyrus, sub cortically)	1 - 7 days before surgery
Secondary	size of craniotomy	in mm ap and lateral	intraoperatively
Secondary	use of intraoperative motor mapping via MEP	yes/no	intraoperatively
Secondary	duration of intraoperative motor mapping via MEP	in min	intraoperatively
Secondary	duration of surgery	in min	intraoperatively
Secondary	extent of resection	in % via volumetry	intraoperatively
Secondary	use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal)	yes/no	intraoperatively