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Completed

NCT Number: NCT02879682

nTMS 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

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Key information

Conditions

Glioma Brain Diseases Brain Metastases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Neurosurgery, Klinikum rechts der Isar, TUM, Munich, Bavaria, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nTMS data available for the surgeon

Procedure

the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • Charite University, Berlin, Germany
  • Evangelisches Krankenhaus Bielefeld gGmbH

Registry information

Official study title

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

Acronym: Motorstim

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Aug 26, 2016
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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