Prospective evaluation of perioperative navigated transcranial magnetic stimulation (nTMS) for neurosurgical procedures

Not Applicable

Recruiting

• Conditions: C71.9; C79.3; Brain, unspecified; Secondary malignant neoplasm of brain and cerebral meninges

• Registration Number: DRKS00025173
• Lead Sponsor: Klinik für Neurochirurgie Klinikum Nürnberg Paracelsus Medizinische Privatuniversität

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patient with brain tumors

Gross total resection or subtotal resection is to achieve

supratentorial tumor localisation

tumor localisation close to functional motor area
or
patients symptomatic with motor deficits

suspected tumor entity: primary or secondary brain tumor

surgical treatment of every of the patient's tumorous lesions

Exclusion Criteria

no MRI possible (cochlea implant, cardiac pacemaker, other implants that do not allow MRI)

CSF fluid diversion

patients with deep brain stimulation devices, spinal cord stimulator or medication pumps

patient refuses participation

patient cannot consent

patients who receive additional nrTMS language mapping

pregnant or breastfeeding female patients

patients with exclusively infratentorial lesions

patients with suspected meningiomas as lesions that should be treated

patients under dialysis

patients with coronary heart disease (myocardial infarction or cardiac stents)

patients with cardiac arrhythmia (first degree AV-block excluded)

cardiac failure NYHA III and NYHA IV

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in tumor diameter (mm) preoperatively and postoperatively<br>

Secondary Outcome Measures

Name	Time	Method
Difference of tumor volume (cm³) preoperatively and postoperatively<br><br>Postoperative neurological status (motor function MRC grade)<br><br>Postoperative neurological status (NIHSS) <br><br>prognostic value of nTMS for postoperative motor function<br><br>prognostic value of nTMS-DTI fibertracking for postoperative motor function<br><br>prognostic value of the distance to fiber tracts regarding residual tumor size<br><br>improvement in nTMS-examination setting according to the answers of the patient questionnaire<br><br>association between postoperative DTI-fibertracking and neurologic outcome<br>