Accidental Awareness During General AnesthesiaNCT07267403
Comparison of Modulations of Motor Brain Activity and SedLine After Median Nerve Stimulation in General Anesthesia
A study testing EEG Headset, SD LTM STIM (Micromed) and SedLine® in people with Accidental Awareness During General Anesthesia, run by Brugmann University Hospital at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Accidental Awareness During General Anesthesia
- What is being tested?
- EEG Headset, SD LTM STIM (Micromed) and SedLine®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 27 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right-handed patient
- Scheduled for surgery using intravenous anesthesia with propofol concentration
Who cannot join
- 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
Show all 9Show fewer
- Upper limb surgery
- Unable to wear an EEG headset (prone position, head and neck surgery)
- Drug abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Seyed Javad Bidgoli, MD, 003224772179, SEYEDJAVAD.BIDGOLI@chu-brugmann.be
About this study
Official title: STIM-PSI: 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.
Read more
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.
- Being tested
- EEG Headset, SD LTM STIM (Micromed), SedLine®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG HeadsetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EEG Headset; Device: SD LTM STIM (Micromed); Device: SedLine® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor activity modulations (ERD/ERS) patterns
Detection of motor activity modulations (ERD/ERS) induced by median nerve stimulation by means of a EEG algorithm
Measured: During the entire anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start27 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental Awareness During General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Besse-Hammer, Brugmann University Hospital
- Investigators
- Seyed Javad Bidgoli, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267403
- Sponsor's protocol ID
- STIM-PSI
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STIM-PSI: Comparison of Modulations of Motor Brain Activity and SedLine After Median Nerve Stimulation in General Anesthesia
- ClinicalTrials.gov ID
- NCT07267403
- Acronym / sponsor ID
- STIM-PSI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sedation by intravenous anesthesia with propofol concentration target. | Experimental | Device: EEG Headset, Device: SD LTM STIM (Micromed), Device: SedLine®Any patient undergoing surgery requiring the use of sedation by intravenous anesthesia with propofol concentration target. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Right-handed patient
- Scheduled for surgery using intravenous anesthesia with propofol concentration
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG Headset64-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. | Device | Sedation by intravenous anesthesia with propofol concentration target. |
| SD LTM STIM (Micromed)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. | Device | Sedation by intravenous anesthesia with propofol concentration target. |
| SedLine®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. | Device | Sedation by intravenous anesthesia with propofol concentration target. |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Accidental Awareness During General Anesthesia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seyed Javad Bidgoli, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG Headset, SD LTM STIM (Micromed) and SedLine® in people with Accidental Awareness During General Anesthesia, run by Brugmann University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seyed Javad Bidgoli, MD (02 477 21 79, seyedjavad.bidgoli@chu-brugmann.be@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor activity modulations (ERD/ERS) patterns (time frame: During the entire anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.