nTMS for Motor Mapping of Rolandic Lesions (Motorstim)

Technical University of Munich

Status and phase: Completed; Phase 3; Phase 2

Conditions: Brain Metastases; Glioma

Treatments: Procedure: nTMS data not available for the surgeon; Procedure: nTMS data available for the surgeon

Study type: Interventional

Funder types: Other

Identifiers

NCT02879682

5496/12

Details and patient eligibility

About

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

Full 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

Enrollment: 330 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

330 participants in 2 patient groups

nTMS

Active Comparator group

Description:

presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation

Treatment:

Procedure: nTMS data available for the surgeon

non-nTMS

Sham Comparator group

Description:

presurgical motor mapping by nTMS without access of the surgeon to these data

Treatment:

Procedure: nTMS data not available for the surgeon