Median nerve stimulation with EEG and SedLine to detect motor brain activity during propofol anesthesia
STIM-PSI: Comparison of Modulations of Motor Brain Activity and SedLine After Median Nerve Stimulation in General Anesthesia
This test uses painless median nerve stimulation plus EEG and SedLine monitoring to see if it can detect movement attempts in right-handed adults having general anesthesia with propofol.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 81 Years |
| Sex | All |
| Sponsor | Brugmann University Hospital Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07267403 on ClinicalTrials.gov |
What this trial studies
Participants will wear an EEG headset centered on the motor cortex while also being monitored with the SedLine Patient State Index (PSI) as they undergo intravenous propofol anesthesia. Painless median nerve stimulation will be applied and event-related synchronization (ERS) in motor cortical EEG and corresponding changes in PSI will be recorded before, during, and up to awakening. The study compares the two signals to characterize whether motor brain responses persist or re-emerge under general anesthesia. These data are intended to explore whether combining EEG motor signals and SedLine could support future automated detection of residual consciousness.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults scheduled for surgery under intravenous propofol anesthesia who can wear an EEG headset and have no peripheral or central nervous system conditions affecting the median nerve or EEG.
Not a fit: Patients with diabetes-related neuropathy, a history of right median nerve injury or right upper limb amputation, BMI under 20 or over 30, pregnancy, or surgeries that prevent EEG headset placement are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could help reveal hidden movement attempts during anesthesia and reduce accidental awareness by improving intraoperative monitoring.
How similar studies have performed: Previous work has shown that combining a brain–computer interface with painless median nerve stimulation can detect motor cortex responses during light propofol sedation, but clinical validation during full general anesthesia is still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Right-handed patient * Scheduled for surgery using intravenous anesthesia with propofol concentration Exclusion Criteria: * Allergy to propofol, soy, or peanuts. * BMI \< 20 or \> 30 * Pregnant or breastfeeding women * Medical or surgical history that may interfere with median nerve stimulation or EEG signal acquisition (e.g., diabetes, polyneuropathy, central neurodegenerative disease, epilepsy, brain surgery) * History of right median nerve injury * Right upper limb amputation * Upper limb surgery * Unable to wear an EEG headset (prone position, head and neck surgery) * Drug abuse
Where this trial is running
Brussels
- CHU Brugmann — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Seyed Javad Bidgoli, MD — CHU Brugmann
- Study coordinator: Seyed Javad Bidgoli, MD
- Email: seyedjavad.bidgoli@chu-brugmann.be@chu-brugmann.be
- Phone: 02 477 21 79
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.