Brain LesionSD-ICUNCT04585503
Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.
A study testing Electrode implantation in people with Brain Lesion and Head Trauma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The progression of brain lesions after severe head trauma or subarachnoid hemorrhage results from extra cranial aggression which is well controlled in intensive care and intracranial aggression which is less well known and therefore less well managed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Lesion, Head Trauma, Subarachnoid Hemorrhage
- What is being tested?
- Electrode implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 7 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > 18 year old
- Patients admitted in neurological reanimation unit for brain lesions after severe head trauma or subarachnoid hemorrhage and requesting a intracranial monitoring or a surgery (evacuation of a hematoma, treatment of an aneurysm, external ventricular bypass).
- Patients affiliated to a social security system
- Patient having been informed and having signed the Consent form OR Close to the patient who has been informed and signed the Consent form OR third party certificate then close consent for further study.
Who cannot join
- Patient with scalp acute infection
- Pregnant or nursing women
- Contre-indication to intracranial surgery
- Patient with not corrected coagulation disorder
- Patient treated with NSAIDS
- Patient treated with under platelet antiaggregants
Show all 10Show fewer
- Patient under legal protection, guardianship, curators
- patients under legal protection
- Patient participating in a study who may interfere with this study.
- people under duress psychiatric care,
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer
Bron, 69500
About this study
The progression of brain lesions after severe head trauma or subarachnoid hemorrhage results from extra cranial aggression which is well controlled in intensive care and intracranial aggression which is less well known and therefore less well managed. The detection of events that can generate new lesions from intracranial monitoring is limited and late once the lesions are irreversible. Invasive cortical depolarizations (SD) can be observed using cortical electrodes and an acquisition system having access to the usually filtered DC signal (0 to 1 Hz). SD are observed at the onset of a new attack of the cortex and spread widely away from the site of aggression. During their propagation, SD generate a significant metabolic demand, and can cause ischemic injury, particularly after meningeal or post-traumatic hemorrhage. SDs are therefore both a marker of new lesion and a mechanism of progression of primary lesions. Yet this type of monitoring is only performed in some expert centers around the world. The analysis of the feasibility and safety of the placement of cortical electrodes in this indication is therefore an essential step to study the clinical benefit of individualized management on the basis of this monitoring.
- Conditions
- Brain Lesion, Head Trauma, Subarachnoid Hemorrhage
- Being tested
- Electrode implantation
- Keywords
- subdural or intra cortical implanted electrodes, CNS monitor, brain lesions
- Medical subject headings
- Craniocerebral Trauma, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrode implantationDevice
The intervention consist in implanting 6 electrodes in subdural or intra cortical position and monitor the central nervous system activity. This monitoring will be additional to the usual monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Central nervous system monitoring | Experimental | Each 20 patients will be implanted with subdural or intra cortical electrodes Receives: Device: Electrode implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Invasive cortical depolarization (SD) recorded in a non-expert center with subdural or intra cortical implanted electrode and central nervous system monitoring.
The feasibility of the study will be objectivized by the availability of a signal of sufficient quality to be exploited, with or without SD: namely a signal without artifact on more than 30% of the recording period on at least 3 electrodes on 6 for at least 12h. The signal analysis should, at least twice a day, allow intervening with the patient if necessary.
Measured: 18 months
Secondary outcomes (8)
Evaluation of electrode implantation safety
Safety will be evaluated recording severe and non-severe adverse events during implantation procedure.
Measured: during implantation procedure
Evaluation of electrode implantation safety
Safety will be evaluated recording severe and non-severe adverse events during monitoring
Measured: during monitoring, maximum 15 days
Evaluation of electrode implantation safety.
Safety will be evaluated recording severe and non-severe adverse events during electrode extraction.
Measured: during electrode extraction
Evaluation of temporality between Invasive cortical depolarization and intracranial hypertension.
proportion of patient with Invasive cortical depolarization before, during and after intracranial hypertension.
Measured: during monitoring, maximum 15 days
Evaluation of temporality between Invasive cortical depolarization and oxygen in tissue decreasing pressure
proportion of patient with Invasive cortical depolarization before during and after oxygen in tissue decreasing.
Measured: during monitoring, maximum 15 days
Evaluation of temporality between Invasive cortical depolarization and detection of a vasospasm
proportion of patient with Invasive cortical depolarization before during and after detection of a vasospasm.
Measured: during monitoring, maximum 15 days
Evaluation of temporality between Invasive cortical depolarizations and EEG change of rhythm.
proportion of patient with Invasive cortical depolarization before, during and after EEG change of rhythm.
Measured: during monitoring, maximum 15 days
Evaluation of temporality between Invasive cortical depolarization and detection of a new cerebral lesion.
proportion of patient with Invasive cortical depolarization before, during and after detection of a new cerebral lesion.
Measured: during monitoring, maximum 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jan 2021
- Primary completion7 Apr 2023
- Study completion7 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain LesionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585503
- Sponsor's protocol ID
- 69HCL19_0615
- Acronym
- SD-ICU
- Status last verified
- Dec 2025
- First submitted
- 7 Oct 2020
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghibaudo V, Bado J, Garcia S, Berthiller J, Rithzenthaler T, Gobert F, Bapteste L, Carrillon R, Bodonian C, Dailler F, Haegelen C, Dumot C, Rheims S, Berhouma M, Balanca B. Lessons to Learn from Multimodal Neuromonitoring of Brain Death with Electrophysiological Markers of Cortical and Subcortical Loss of Functions. Neurocrit Care. 2024 Dec;41(3):1110-1114. doi: 10.1007/s12028-024-02049-4. Epub 2024 Jul 9. No abstract available.
PubMed 38982002Balanca B, Ghibaudo V, Bado J, Berthiller J, Ritzenthaler T, Gobert F, Bapteste L, Carrillon R, Bodonian C, Contard F, Percevault G, Marinesco S, Dreier JP, Woitzik J, Haegelen C, Rheims S, Dumot C, Dailler F, Berhouma M. Feasibility and safety of electrocorticography monitoring after acute brain injury to detect cortical spreading depolarisation, a prospective observational study in a neurological intensive care unit. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101669. doi: 10.1016/j.accpm.2025.101669. Epub 2025 Nov 13.
PubMed 41241268
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.
- ClinicalTrials.gov ID
- NCT04585503
- Acronym / sponsor ID
- SD-ICU / 69HCL19_0615
- Conditions
- Brain Lesion, Head Trauma, Subarachnoid Hemorrhage
- Keywords
- subdural or intra cortical implanted electrodes, CNS monitor, brain lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 14 Oct 2020 (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.
The progression of brain lesions after severe head trauma or subarachnoid hemorrhage results from extra cranial aggression which is well controlled in intensive care and intracranial aggression which is less well known and therefore less well managed. The detection of events that can generate new lesions from intracranial monitoring is limited and late once the lesions are irreversible. Invasive cortical depolarizations (SD) can be observed using cortical electrodes and an acquisition system having access to the usually filtered DC signal (0 to 1 Hz). SD are observed at the onset of a new attack of the cortex and spread widely away from the site of aggression. During their propagation, SD generate a significant metabolic demand, and can cause ischemic injury, particularly after meningeal or post-traumatic hemorrhage. SDs are therefore both a marker of new lesion and a mechanism of progression of primary lesions. Yet this type of monitoring is only performed in some expert centers around the world. The analysis of the feasibility and safety of the placement of cortical electrodes in this indication is therefore an essential step to study the clinical benefit of individualized management on the basis of this monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Central nervous system monitoring | Experimental | Device: Electrode implantationEach 20 patients will be implanted with subdural or intra cortical electrodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient > 18 year old
- Patients admitted in neurological reanimation unit for brain lesions after severe head trauma or subarachnoid hemorrhage and requesting a intracranial monitoring or a surgery (evacuation of a hematoma, treatment of an aneurysm, external ventricular bypass).
- Patients affiliated to a social security system
- Patient having been informed and having signed the Consent form OR Close to the patient who has been informed and signed the Consent form OR third party certificate then close consent for further study.
Key exclusion criteria (10 listed)
- Patient with scalp acute infection
- Pregnant or nursing women
- Contre-indication to intracranial surgery
- Patient with not corrected coagulation disorder
- Patient treated with NSAIDS
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 |
|---|---|---|
| Electrode implantationThe intervention consist in implanting 6 electrodes in subdural or intra cortical position and monitor the central nervous system activity. This monitoring will be additional to the usual monitoring. | Device | Central nervous system monitoring |
Primary outcome
Evaluation of Invasive cortical depolarization (SD) recorded in a non-expert center with subdural or intra cortical implanted electrode and central nervous system monitoring.
Time frame: 18 months
The feasibility of the study will be objectivized by the availability of a signal of sufficient quality to be exploited, with or without SD: namely a signal without artifact on more than 30% of the recording period on at least 3 electrodes on 6 for at least 12h. The signal analysis should, at least twice a day, allow intervening with the patient if necessary.
8 secondary outcomes
Evaluation of electrode implantation safety
Time frame: during implantation procedure
Evaluation of electrode implantation safety
Time frame: during monitoring, maximum 15 days
Evaluation of electrode implantation safety.
Time frame: during electrode extraction
Evaluation of temporality between Invasive cortical depolarization and intracranial hypertension.
Time frame: during monitoring, maximum 15 days
Evaluation of temporality between Invasive cortical depolarization and oxygen in tissue decreasing pressure
Time frame: during monitoring, maximum 15 days
Evaluation of temporality between Invasive cortical depolarization and detection of a vasospasm
Time frame: during monitoring, maximum 15 days
Evaluation of temporality between Invasive cortical depolarizations and EEG change of rhythm.
Time frame: during monitoring, maximum 15 days
Evaluation of temporality between Invasive cortical depolarization and detection of a new cerebral lesion.
Time frame: during monitoring, maximum 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 38982002Ghibaudo V, Bado J, Garcia S, Berthiller J, Rithzenthaler T, Gobert F, Bapteste L, Carrillon R, Bodonian C, Dailler F, Haegelen C, Dumot C, Rheims S, Berhouma M, Balanca B. Lessons to Learn from Multimodal Neuromonitoring of Brain Death with Electrophysiological Markers of Cortical and Subcortical Loss of Functions. Neurocrit Care. 2024 Dec;41(3):1110-1114. doi: 10.1007/s12028-024-02049-4. Epub 2024 Jul 9. No abstract available.
- Derived from this study: PubMed 41241268Balanca B, Ghibaudo V, Bado J, Berthiller J, Ritzenthaler T, Gobert F, Bapteste L, Carrillon R, Bodonian C, Contard F, Percevault G, Marinesco S, Dreier JP, Woitzik J, Haegelen C, Rheims S, Dumot C, Dailler F, Berhouma M. Feasibility and safety of electrocorticography monitoring after acute brain injury to detect cortical spreading depolarisation, a prospective observational study in a neurological intensive care unit. Anaesth Crit Care Pain Med. 2026 Jul;45(4):101669. doi: 10.1016/j.accpm.2025.101669. Epub 2025 Nov 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrode implantation in people with Brain Lesion and Head Trauma, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 19 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Invasive cortical depolarization (SD) recorded in a non-expert center with subdural or intra cortical implanted electrode and central nervous system monitoring. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585503, which also lists 2 linked publications.
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 19 Dec 2025.