Improving brain surgery monitoring techniques
Official title: Optimization of Transcranial Motor Evoked Potentials in Supratentorial Surgeries
Run by Insel Gruppe AG, University Hospital Bern · NCT06480370 · Data updated 2026-11-12
This study is testing new ways to monitor brain activity during surgery to help prevent movement and reduce the chance of patients having motor problems after the operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 203 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | February 20, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | December 2028 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT06480370 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with a supra-tentorial lesion requiring surgery and who will undergo neurosurgery with MEP monitoring.
✕Probably not a fit
Patients who do not require MEP monitoring or those who are in emergency situations without prior consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project focuses on enhancing the methodology for eliciting transcranial motor evoked potentials (MEPs) during supratentorial brain surgeries. It aims to optimize intraoperative neurophysiological monitoring by utilizing accelerometer measurements and microscope video imaging to minimize movement during brain stimulation. The study will assess various stimulation parameters and recording techniques to improve the accuracy and effectiveness of MEP monitoring, ultimately aiming to reduce the risk of post-operative motor deficits.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced motor deficits for patients undergoing brain surgery.
How similar studies have gone: Other studies have shown promise in optimizing intraoperative monitoring techniques, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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's running
-
Dep. of Neurosurgery, Bern University Hospital
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Seidel Kathleen, MD — Department of Neurosurgery
- Study coordinator: Seidel Kathleen, MD
- Email: kathleen.seidel@insel.ch
- Phone: +41 31 632 57 88
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.