nTMS for Motor Mapping of Rolandic Lesions (Motorstim)

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

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

Study Overview

• Status: Completed
• Conditions: Glioma; Brain Metastases
• Intervention / Treatment: Procedure: nTMS data available for the surgeon; Procedure: nTMS data not available for 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

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité Universitätsmedizin Berlin
  • Berlin, Germany
    • Vivantes Klinikum Neu-Kölln
  • Bielefeld, Germany
    • Klinikum Bielefeld
  • Günzburg, Germany
    • Klinikum Günzburg
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Department of Neurosurgery, Klinikum rechts der Isar, TUM
• Italy
  • Messina, Italy
    • Department of Neurosurgery, University of Messina
• Switzerland
  • Bern, Switzerland
    • Universität Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nTMS; presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation	Procedure: nTMS data available for the surgeon; the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon
Sham Comparator: non-nTMS; presurgical motor mapping by nTMS without access of the surgeon to these data	Procedure: nTMS data not available for the surgeon; the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale	deterioration in NIHSS score	3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changed indication for surgery	towards surgery, avoids surgery towards biopsy, avoids surgery towards follow-up	1 - 7 days before surgery
change of the approach	using a different direct to approach the lesion (different sulcus, gyrus, sub cortically)	1 - 7 days before surgery
size of craniotomy	in mm ap and lateral	intraoperatively
use of intraoperative motor mapping via MEP	yes/no	intraoperatively
duration of intraoperative motor mapping via MEP	in min	intraoperatively
duration of surgery	in min	intraoperatively
extent of resection	in % via volumetry	intraoperatively
use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal)	yes/no	intraoperatively

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: Charite University, Berlin, Germany; Evangelisches Krankenhaus Bielefeld gGmbH
• Investigators: Principal Investigator: Sandro M Krieg, MD, MBA, Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimated): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: glioma; brain metastases; nTMS
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: 5496/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO