Optimization of Transcranial Motor Evoked Potentials in Supratentorial Surgeries
Recruiting now · Not applicable
Conditions studied: Surgery
In brief
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.
Key facts
- Study ID
- NCT06480370
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 203
- Starts
- 2025-02-20
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Dep. of Neurosurgery, Bern University Hospital — Bern, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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