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NCT Number: NCT07267403

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

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.

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Key information

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EEG Headset

Device

64-electrode device (including 16 on the motor cortex), placed on the scalp. The EEG measurement is performed using OpenViBE software, in conjunction with an Eego amplifier (64 electrodes, ANT Neuro), both CE certified.

SD LTM STIM (Micromed)

Device

Median nerve stimulation: applied to the right forearm using two ECG electrodes positioned at the wrist (palmar side), allowing painless transcutaneous stimulation (intensity 3 to 14 mA; pulse duration: 0.1 ms; frequency: 5 Hz). The stimulator used is a SD LTM STIM model (Micromed), CE certified.

SedLine®

Device

Anesthetic depth monitoring: Performed using the SedLine® Brain Function Monitoring device (Masimo Corporation, model RDS7A, CE certified), using four forehead electrodes to record EEG activity. The Patient State Index (PSi), calculated in real time, is interpreted within a target range of 25 to 50 to ensure adequate general anesthesia. The device complies with international standards for electrical safety (IEC 60601) and hospital use.

Primary outcomes

  1. Motor activity modulations (ERD/ERS) patterns

    Time frame: During the entire anesthesia

    Detection of motor activity modulations (ERD/ERS) induced by median nerve stimulation by means of a EEG algorithm

Study contacts

Contact information is provided by the study sponsor or research team.

Seyed Javad Bidgoli, MD

CONTACT

[email protected]@chu-brugmann.be

02 477 21 79

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Official study title

STIM-PSI: Comparison of Modulations of Motor Brain Activity and SedLine After Median Nerve Stimulation in General Anesthesia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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