RecruitingNot ApplicableNCT06480370

Optimization of Transcranial Motor Evoked Potentials in Supratentorial Surgeries

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

203 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

Surgery

Summary

This project aims to optimize the methodology to elicite transcranial motor evoked potentials in intraoperative neurophysiological monitoring of brain surgery. It includes accelerometer measurements and microscope video image to determine movement of the surgical field, making possible minimization of movement during brain stimulation.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Informed consent signed by the subject
The patient has a supra-tentorial lesion requiring surgery
The patient is undergoing neurosurgery with the use of MEP monitoring during surgery to protect functional tissue* (During routine preparation for the surgery, patients are checked for any relative contraindications as listed in the user manual of the ISIS IOM System (see p. 11, chapter 2.2.4 of the user manual). Every relative contraindication must be weighed against the risk and benefits of the measurement signals which are routinely needed for the surgical intervention. There are no absolute contraindications for the ISIS IOM System.)
The patient is older than 18 years

Exclusion Criteria9

No need for MEP monitoring
Vulnerable subjects (pregnant, impaired consciousness)
People who do not want to participate in the study
Emergency procedures in which no consent was obtained before the operation
Multiple surgeries on the same patient
Preoperative non-affected arm or leg motor deficit (MRC <5), that is to say, no motor deficit of the arm or leg ipsilateral to the surgery
Inhalational anesthesia
Persisting neuromuscular blockade
Impossibility to place the stimulating or recording electrodes in the appropriate site