NCT02879682

nTMS for Motor Mapping of Rolandic Lesions

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Glioma
• Brain Metastases

Interventions

Type	Name	Description
PROCEDURE	nTMS data available for the surgeon	the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon
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

Timeline

• Start date: 2016-08-01
• Primary completion: 2022-06-01
• Completion: 2023-04-01
• First posted: 2016-08-26
• Last updated: 2023-06-01

Locations

7 sites across 3 countries: Germany, Italy, Switzerland