Actively Recruiting

Phase Not Applicable
Age: 18Years - 81Years
All Genders
NCT07267403

Comparison of Modulations of Motor Brain Activity and SedLine After Median Nerve Stimulation in General Anesthesia

Led by Brugmann University Hospital · Updated on 2025-12-05

48

Participants Needed

1

Research Sites

61 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To this date, no monitoring device can reliably detect episodes of accidental awakening during general anesthesia. One promising approach is the use of electroencephalography (EEG) to detect movement attempts via a brain-computer interface (BCI). Previous work has shown that combining a BCI with painless median nerve stimulation can detect cerebral motor activity under light propofol sedation. However, clinical data are still lacking regarding the persistence or otherwise of a cerebral motor response (neural synchronization, or ERS) induced by this stimulation during general anesthesia. In this new study, the aim is to simultaneously record the EEG centered on the motor cortex and the signal from the SedLine Patient State Index (PSI) to better characterize the evolution of cerebral motor activity before, during general anesthesia, and up to awakening. This approach will allow us to explore the complementarity of the two signals for future automated detection of residual states of consciousness during surgery. Preliminary data from a previous protocol (STIM-MOTANA) allowed to develop an EEG classification algorithm based on Riemannian geometry, capable of inferring a patient's state of consciousness from cortical responses induced by median nerve stimulation. The objective of this new study is also to compare the sensitivity of this algorithm with that of PSI, in order to assess its potential as a complementary - or even alternative - indicator of the level of consciousness under general anesthesia. Investigators hypothesize that it is possible to detect, using EEG, specific brain signatures related to median nerve stimulation, including during propofol-induced general anesthesia. Specifically, neuronal desynchronization and resynchronization phases (ERD/ERS), well characterized in wakefulness or light sedation, could partially persist at higher propofol concentrations. Parallel PSI recording will allow analyzing to what extent these EEG modulations are related to classically measured levels of consciousness, and to validate the relevance of the new algorithm based on Riemannian geometry as a tool for detecting intra-operative arousals.

CONDITIONS

Official Title

Comparison of Modulations of Motor Brain Activity and SedLine After Median Nerve Stimulation in General Anesthesia

Who Can Participate

Age: 18Years - 81Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Right-handed patient
  • Scheduled for surgery using intravenous anesthesia with propofol concentration
  • Age between 18 and 81 years
  • Able to wear an EEG headset
Not Eligible

You will not qualify if you...

  • Allergy to propofol, soy, or peanuts
  • Body mass index (BMI) less than 20 or greater than 30
  • Pregnant or breastfeeding women
  • Medical or surgical history interfering with median nerve stimulation or EEG, including diabetes, polyneuropathy, neurodegenerative diseases, epilepsy, or brain surgery
  • History of right median nerve injury
  • Right upper limb amputation
  • History of upper limb surgery
  • Unable to wear an EEG headset due to prone position or head and neck surgery
  • History of drug abuse

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

CHU Brugmann

Brussels, Belgium, 1020

Actively Recruiting

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Research Team

S

Seyed Javad Bidgoli, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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