Clinical trial · Interventional
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
NCT02879682CI-TRIAL-00066846MotorstimcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nTMS data available for the surgeon | Procedure | — | UNRESOLVED |
| nTMS data not available for the surgeon | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- nTMS
- description
- presurgical motor mapping by nTMS and fusion with intraoperative neuronavigation
- interventionNames
- Procedure: nTMS data available for the surgeon
- type
- SHAM_COMPARATOR
- label
- non-nTMS
- description
- presurgical motor mapping by nTMS without access of the surgeon to these data
- interventionNames
- Procedure: nTMS data not available for the surgeon
Primary outcomes (1)
- measure
- Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.