Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
330 participants
INTERVENTIONAL
2016-08-31
2023-04-30
Brief Summary
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Primary objective: Permanently new postoperative deficit is lower when the preoperative motor mapping is available to the surgeon
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
QUADRUPLE
Study Groups
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nTMS
presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation
nTMS data available for the surgeon
the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon
non-nTMS
presurgical motor mapping by nTMS without access of the surgeon to these data
nTMS data not available for the surgeon
the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* preoperative nTMS mapping of the ipsilateral hemisphere
* implementation of the mapping data into preoperative planning
* continuous MEP monitoring - informed consent
Exclusion Criteria
* infratentorial tumor
* no postoperative imaging
* prognosis lower than 3 months of survival - age \<18 years
18 Years
95 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Evangelisches Krankenhaus Bielefeld gGmbH
OTHER
Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Sandro M Krieg, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Technical University of Munich
Locations
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Department of Neurosurgery, Klinikum rechts der Isar, TUM
Munich, Bavaria, Germany
Charité Universitätsmedizin Berlin
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
Countries
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Other Identifiers
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5496/12
Identifier Type: -
Identifier Source: org_study_id
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