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nTMS for Motor Mapping of Rolandic Lesions (Motorstim)

Primary Purpose

Glioma, Brain Metastases

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nTMS data available for the surgeon
nTMS data not available for the surgeon
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma focused on measuring glioma, brain metastases, nTMS

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurosurgery, Klinikum rechts der Isar, TUM
  • Charité Universitätsmedizin Berlin
  • Vivantes Klinikum Neu-Kölln
  • Klinikum Bielefeld
  • Klinikum Günzburg
  • Department of Neurosurgery, University of Messina
  • Universität Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

nTMS

non-nTMS

Arm Description

presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation

presurgical motor mapping by nTMS without access of the surgeon to these data

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 12, 2016
Last Updated
May 30, 2023
Sponsor
Technical University of Munich
Collaborators
Charite University, Berlin, Germany, Evangelisches Krankenhaus Bielefeld gGmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02879682
Brief Title
nTMS for Motor Mapping of Rolandic Lesions
Acronym
Motorstim
Official Title
Randomized Controlled Multicenter Trial on the Impact of Presurgical Navigated Transcranial Magnetic Stimulation for Motor Mapping of Rolandic Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
April 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
Collaborators
Charite University, Berlin, Germany, Evangelisches Krankenhaus Bielefeld gGmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Brain Metastases
Keywords
glioma, brain metastases, nTMS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
preoperative Mapping
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nTMS
Arm Type
Active Comparator
Arm Description
presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation
Arm Title
non-nTMS
Arm Type
Sham Comparator
Arm Description
presurgical motor mapping by nTMS without access of the surgeon to these data
Intervention Type
Procedure
Intervention Name(s)
nTMS data available for the surgeon
Intervention Description
the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon
Intervention Type
Procedure
Intervention Name(s)
nTMS data not available for the surgeon
Intervention Description
the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon
Primary Outcome Measure Information:
Title
Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale
Description
deterioration in NIHSS score
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
changed indication for surgery
Description
towards surgery, avoids surgery towards biopsy, avoids surgery towards follow-up
Time Frame
1 - 7 days before surgery
Title
change of the approach
Description
using a different direct to approach the lesion (different sulcus, gyrus, sub cortically)
Time Frame
1 - 7 days before surgery
Title
size of craniotomy
Description
in mm ap and lateral
Time Frame
intraoperatively
Title
use of intraoperative motor mapping via MEP
Description
yes/no
Time Frame
intraoperatively
Title
duration of intraoperative motor mapping via MEP
Description
in min
Time Frame
intraoperatively
Title
duration of surgery
Description
in min
Time Frame
intraoperatively
Title
extent of resection
Description
in % via volumetry
Time Frame
intraoperatively
Title
use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal)
Description
yes/no
Time Frame
intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandro M Krieg, MD, MBA
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery, Klinikum rechts der Isar, TUM
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum Neu-Kölln
City
Berlin
Country
Germany
Facility Name
Klinikum Bielefeld
City
Bielefeld
Country
Germany
Facility Name
Klinikum Günzburg
City
Günzburg
Country
Germany
Facility Name
Department of Neurosurgery, University of Messina
City
Messina
Country
Italy
Facility Name
Universität Bern
City
Bern
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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nTMS for Motor Mapping of Rolandic Lesions

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