nTMS for Motor Mapping of Rolandic Lesions

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Glioma, Brain Metastases

Intervention / Treatment
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* Procedure: nTMS data available for the surgeon
* Procedure: nTMS data not available for the surgeon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: preoperative Mapping
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glioma, brain metastases, nTMS