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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
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
Age
18 - 95 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
August 1, 2016
Primary Completion Date
June 1, 2022
Completion Date
April 1, 2023
Last Updated
June 1, 2023
330
ACTUAL participants
nTMS data available for the surgeon
PROCEDURE
nTMS data not available for the surgeon
PROCEDURE
Lead Sponsor
Technical University of Munich
Collaborators
NCT05692635
NCT05099003
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05839379