Brain Metastases, Glioma
Conditions
Keywords
glioma, brain metastases, nTMS
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
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
Interventions
PROCEDUREnTMS data available for the surgeon
the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon
PROCEDUREnTMS data not available for the surgeon
the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon
Sponsors
Charite University, Berlin, Germany
Evangelisches Krankenhaus Bielefeld gGmbH
Technical University of Munich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
preoperative Mapping
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation-related neurological motor deficit 3 months after surgery as measured by NIHSS scale | 3 months after surgery | deterioration in NIHSS score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of the approach | 1 - 7 days before surgery | using a different direct to approach the lesion (different sulcus, gyrus, sub cortically) |
| size of craniotomy | intraoperatively | in mm ap and lateral |
| use of intraoperative motor mapping via MEP | intraoperatively | yes/no |
| changed indication for surgery | 1 - 7 days before surgery | towards surgery, avoids surgery towards biopsy, avoids surgery towards follow-up |
| duration of surgery | intraoperatively | in min |
| extent of resection | intraoperatively | in % via volumetry |
| use of further modalities (fMRI, DTI fiber tracking, SSEP phase reversal) | intraoperatively | yes/no |
| duration of intraoperative motor mapping via MEP | intraoperatively | in min |
Countries
Germany, Italy, Switzerland
Outcome results
None listed