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Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions. (SD-ICU)

Primary Purpose

Brain Lesion, Head Trauma, Subarachnoid Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrode implantation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Lesion focused on measuring subdural or intra cortical implanted electrodes, CNS monitor, brain lesions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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,

Sites / Locations

  • Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre WertheimerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Central nervous system monitoring

Arm Description

Each 20 patients will be implanted with subdural or intra cortical electrodes

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Evaluation of electrode implantation safety
Safety will be evaluated recording severe and non-severe adverse events during implantation procedure.
Evaluation of electrode implantation safety
Safety will be evaluated recording severe and non-severe adverse events during monitoring
Evaluation of electrode implantation safety.
Safety will be evaluated recording severe and non-severe adverse events 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.
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.
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.
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.
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.

Full Information

First Posted
October 7, 2020
Last Updated
July 6, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT04585503
Brief Title
Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.
Acronym
SD-ICU
Official Title
Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Lesion, Head Trauma, Subarachnoid Hemorrhage
Keywords
subdural or intra cortical implanted electrodes, CNS monitor, brain lesions

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Central nervous system monitoring
Arm Type
Experimental
Arm Description
Each 20 patients will be implanted with subdural or intra cortical electrodes
Intervention Type
Device
Intervention Name(s)
Electrode implantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of Invasive cortical depolarization (SD) recorded in a non-expert center with subdural or intra cortical implanted electrode and central nervous system monitoring.
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Evaluation of electrode implantation safety
Description
Safety will be evaluated recording severe and non-severe adverse events during implantation procedure.
Time Frame
during implantation procedure
Title
Evaluation of electrode implantation safety
Description
Safety will be evaluated recording severe and non-severe adverse events during monitoring
Time Frame
during monitoring, maximum 15 days
Title
Evaluation of electrode implantation safety.
Description
Safety will be evaluated recording severe and non-severe adverse events during electrode extraction.
Time Frame
during electrode extraction
Title
Evaluation of temporality between Invasive cortical depolarization and intracranial hypertension.
Description
proportion of patient with Invasive cortical depolarization before, during and after intracranial hypertension.
Time Frame
during monitoring, maximum 15 days
Title
Evaluation of temporality between Invasive cortical depolarization and oxygen in tissue decreasing pressure
Description
proportion of patient with Invasive cortical depolarization before during and after oxygen in tissue decreasing.
Time Frame
during monitoring, maximum 15 days
Title
Evaluation of temporality between Invasive cortical depolarization and detection of a vasospasm
Description
proportion of patient with Invasive cortical depolarization before during and after detection of a vasospasm.
Time Frame
during monitoring, maximum 15 days
Title
Evaluation of temporality between Invasive cortical depolarizations and EEG change of rhythm.
Description
proportion of patient with Invasive cortical depolarization before, during and after EEG change of rhythm.
Time Frame
during monitoring, maximum 15 days
Title
Evaluation of temporality between Invasive cortical depolarization and detection of a new cerebral lesion.
Description
proportion of patient with Invasive cortical depolarization before, during and after detection of a new cerebral lesion.
Time Frame
during monitoring, maximum 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baptiste BALANCA, Dr
Phone
04.72.35.75.76
Ext
+33
Email
baptiste.balanca@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BERTHILLER
Phone
04 72 11 80 67
Ext
+33
Email
julien.berthiller@chu-lyon.fr
Facility Information:
Facility Name
Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baptiste BALANCA, Dr
Phone
04.72.35.75.76
Ext
+33
Email
baptiste.balanca@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Baptiste BALANCA, Dr
First Name & Middle Initial & Last Name & Degree
Anne-Claire LUKASZEWICZ, Pr
First Name & Middle Initial & Last Name & Degree
Frédéric DAILLER, Dr
First Name & Middle Initial & Last Name & Degree
Moncef BERHOUMA, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.

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