Exploring brain activity changes from median nerve stimulation during anesthesia
Study of Modulations of Motor Brain Activity Following Stimulation of the Median Nerve During General Anesthesia
This study is testing if using median nerve stimulation can help doctors detect if high-risk patients are aware during surgery while they're under anesthesia, to improve safety and monitoring.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 81 Years |
| Sex | Male |
| Sponsor | Brugmann University Hospital Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05272202 on ClinicalTrials.gov |
What this trial studies
This investigation focuses on accidental awareness during general anesthesia, which affects 1-2% of high-risk patients and can lead to severe psychological trauma. The study aims to utilize median nerve stimulation to create a brain-computer interface (BCI) that detects movement intention through EEG measurements. By analyzing brain activity patterns, the researchers hope to alert anesthetists to a patient's awareness during surgery. This innovative approach could enhance patient safety and improve monitoring techniques in anesthesia.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults aged 18 to 81 scheduled for surgery requiring intravenous anesthesia with propofol.
Not a fit: Patients with allergies to propofol or those with certain medical histories that interfere with nerve stimulation or EEG signal acquisition may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of psychological trauma associated with accidental awareness during anesthesia.
How similar studies have performed: While the approach of using median nerve stimulation and BCI for monitoring during anesthesia is innovative, similar studies have not been widely reported, indicating this may be a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>18 years and \<81 years * Right-handed * Programmed for surgery with the use of an intravenous anesthesia with a propofol concentration objective Exclusion Criteria: * Allergy to propofol, soy or peanuts * BMI\<20 or \>30 * Pregnant or breastfeeding women * Adult unable to give consent * Medical or surgical history that may interfere with median nerve stimulation or the obtention of the EEG signal (for example: diabetes, polyneuropathy, central neurodegenerative disease, epilepsy, brain surgery) * History of right median nerve injury * Amputation of the upper right limb * Impossibility of affixing an EEG helmet * Addiction
Where this trial is running
Brussels
- CHU Brugmann — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Denis Schmartz, MD — CHU Brugmann
- Study coordinator: Denis Schmartz, MD
- Email: Denis.SCHMARTZ@chu-brugmann.be
- Phone: 3224773734
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.