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Clinical Trials/NCT07267403
NCT07267403RecruitingNot Applicable

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

Brugmann University Hospital1 site in 1 country48 target enrollmentStarted: October 27, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
48
Locations
1
Primary Endpoint
Motor activity modulations (ERD/ERS) patterns

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 81 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Sedation by intravenous anesthesia with propofol concentration target.

Experimental

Any patient undergoing surgery requiring the use of sedation by intravenous anesthesia with propofol concentration target.

Intervention: EEG Headset (Device)

Sedation by intravenous anesthesia with propofol concentration target.

Experimental

Any patient undergoing surgery requiring the use of sedation by intravenous anesthesia with propofol concentration target.

Intervention: SD LTM STIM (Micromed) (Device)

Sedation by intravenous anesthesia with propofol concentration target.

Experimental

Any patient undergoing surgery requiring the use of sedation by intravenous anesthesia with propofol concentration target.

Intervention: SedLine® (Device)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tatiana Besse-Hammer

Head of clinical research unit

Brugmann University Hospital

Study Sites (1)

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