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nTMS for Motor Mapping of Rolandic Lesions (Motorstim)

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ClinicalTrials.gov Identifier: NCT02879682
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : August 4, 2020
Sponsor:
Collaborators:
Charite University, Berlin, Germany
Evangelisches Krankenhaus Bielefeld gGmbH
Information provided by (Responsible Party):
Technische Universität München

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


Condition or disease Intervention/treatment Phase
Glioma Brain Metastases Procedure: nTMS data available for the surgeon Procedure: nTMS data not available for the surgeon Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Multicenter Trial on the Impact of Presurgical Navigated Transcranial Magnetic Stimulation for Motor Mapping of Rolandic Lesions
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: nTMS
presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation
Procedure: nTMS data available for the surgeon
the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon

Sham Comparator: non-nTMS
presurgical motor mapping by nTMS without access of the surgeon to these data
Procedure: nTMS data not available for the surgeon
the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon




Primary Outcome Measures :
  1. Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale [ Time Frame: 3 months after surgery ]
    deterioration in NIHSS score


Secondary Outcome Measures :
  1. changed indication for surgery [ Time Frame: 1 - 7 days before surgery ]
    towards surgery, avoids surgery towards biopsy, avoids surgery towards follow-up

  2. change of the approach [ Time Frame: 1 - 7 days before surgery ]
    using a different direct to approach the lesion (different sulcus, gyrus, sub cortically)

  3. size of craniotomy [ Time Frame: intraoperatively ]
    in mm ap and lateral

  4. use of intraoperative motor mapping via MEP [ Time Frame: intraoperatively ]
    yes/no

  5. duration of intraoperative motor mapping via MEP [ Time Frame: intraoperatively ]
    in min

  6. duration of surgery [ Time Frame: intraoperatively ]
    in min

  7. extent of resection [ Time Frame: intraoperatively ]
    in % via volumetry

  8. use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal) [ Time Frame: intraoperatively ]
    yes/no



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879682


Contacts
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Contact: Sandro M Krieg, MD, MBA +498941409482 sandro.krieg@tum.de
Contact: Sebastian Ille, MD +498941405693 sebastian.ille@tum.de

Locations
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Germany
Department of Neurosurgery, Klinikum rechts der Isar, TUM Recruiting
Munich, Bavaria, Germany, 81675
Contact: Sandro Krieg, MD    8941402151    sandro.krieg@tum.de   
Contact: Sebastian Ille, MD    8941402151    sebastian.ille@tum.de   
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Thomas Picht, MD       thomas.picht@charite.de   
Vivantes Klinikum Neu-Kölln Recruiting
Berlin, Germany
Contact: Stefanie Maurer, MD       Stefanie.Maurer@vivantes.de   
Klinikum Bielefeld Recruiting
Bielefeld, Germany
Contact: Sami Ridwan, MD       sami.ridwan@yahoo.de   
Klinikum Günzburg Recruiting
Günzburg, Germany
Contact: Jan Coburger, MD       jan.coburger@uni-ulm.de   
Italy
Department of Neurosurgery, University of Messina Recruiting
Messina, Italy
Contact: Giovanni Raffa, MD       giovanni.raffa@unime.it   
Switzerland
Universität Bern Recruiting
Bern, Switzerland
Contact: Kathleen Seidel, MD         
Sponsors and Collaborators
Technische Universität München
Charite University, Berlin, Germany
Evangelisches Krankenhaus Bielefeld gGmbH
Investigators
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Principal Investigator: Sandro M Krieg, MD, MBA Technische Universität München
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02879682    
Other Study ID Numbers: 5496/12
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Technische Universität München:
glioma
brain metastases
nTMS
Additional relevant MeSH terms:
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Neoplasm Metastasis
Glioma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue