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Investigation of Cerebral Motor Activity Modulations Following Median Nerve Stimulation During General Anaesthesia

RecruitingEARLY Phase 1Ages 18 Years - 81 YearsMaleBrugmann University Hospital
NCT05272202 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Accidental Awareness during General Anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Actually, no monitoring techniques can accurately predict or detect an AAGA. Since the first reflex for a patient during an AAGA is to move, a brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. The investigators previously showed that median nerve stimulation (MNS) could be the keystone of a BCI specialized in the detection of movement intention. Indeed, based on these previous results, the investigators can envisage a routine system where the patient would be stimulated at the median nerve position, while a BCI device would analyze the event-related desynchronization (ERD) and event-related synchronization (ERS) modulati

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📋 Eligibility rules (as published)
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
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What it tests

  • Propofol
  • Median nerve stimulation
  • EEG measurements
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Where

1 site
CHU Brugmann
Brussels, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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