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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| Evangelisches Krankenhaus Bielefeld gGmbH | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nTMS | Active Comparator | presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation |
|
| non-nTMS | Sham Comparator | presurgical motor mapping by nTMS without access of the surgeon to these data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nTMS data available for the surgeon | Procedure | the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon |
|
| 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 |
| 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) |
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Key inclusion criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandro M Krieg, MD, MBA | Technical University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, Klinikum rechts der Isar, TUM | Munich | Bavaria | 81675 | Germany | ||
| Charité Universitätsmedizin Berlin |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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preoperative Mapping
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| nTMS data not available for the surgeon | Procedure | the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon |
|
| 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 |
| Berlin |
| Germany |
| Vivantes Klinikum Neu-Kölln | Berlin | Germany |
| Klinikum Bielefeld | Bielefeld | Germany |
| Klinikum Günzburg | Günzburg | Germany |
| Department of Neurosurgery, University of Messina | Messina | Italy |
| Universität Bern | Bern | Switzerland |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |