Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408428
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-01-23
Brief Title:
Glioma Intraoperative MicroElectroCorticoGraphy
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
Glioma Intraoperative MicroElectroCorticoGraphy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MicroECoGG
Brief Summary:
The goal of this clinical trial is to validate the safety and to assess the quality of the signals provided by newly developed micro ElectroCorticoGraphy electrodes provided by the company Panaxium based on conductive polymers PEDOTPSS in patients suffering of gliomas during resection surgery performed in awake condition The main questions it aims to answer are
Safety of PEDOTPSS microECoGs by assessing the rate of serious adverse events associated with their use during glioma surgery
Quality of PEDOTPSS microECoGs recordings as compared with recordings with traditional macroelectrodes assessed by signal-to-noise ratio impedance ability to detect ripples 100-250 Hz and fast ripples 250-600 Hz ability to record epileptic activity spikes and equivalent either spontaneously or following direct electrical stimulation afterdischarges
Practicality of microelectrodes use as perceived by neurosurgeons
Exploratory objectives ability to record multi-unit activity correlation between microECoG activity and tumor infiltration - local oncometabolite concentrations determination of epileptic seizure rate during electrode use
Participants will be recorded during awake glioma surgery by the newly developed micro ElectroCorticoGraphy electrodes and by routine macroelectrodes as standard of care during both mapping of cortical activities and electrical stimulations used to assess the functional mapping mandatory for tailored tumor resection
Safety of PEDOTPSS microECoGs by assessing the rate of serious adverse events associated with their use during glioma surgery
Quality of PEDOTPSS microECoGs recordings as compared with recordings with traditional macroelectrodes assessed by signal-to-noise ratio impedance ability to detect ripples 100-250 Hz and fast ripples 250-600 Hz ability to record epileptic activity spikes and equivalent either spontaneously or following direct electrical stimulation afterdischarges
Practicality of microelectrodes use as perceived by neurosurgeons
Exploratory objectives ability to record multi-unit activity correlation between microECoG activity and tumor infiltration - local oncometabolite concentrations determination of epileptic seizure rate during electrode use
Participants will be recorded during awake glioma surgery by the newly developed micro ElectroCorticoGraphy electrodes and by routine macroelectrodes as standard of care during both mapping of cortical activities and electrical stimulations used to assess the functional mapping mandatory for tailored tumor resection
Detailed Description:
Electroencephalography EEG is a widely-used tool for studying brain activity developed in humans in the late 1920s Its indications have evolved as brain imaging techniques have developed but it remains extremely useful in the fields of epileptology comas brain death post-anoxic metabolic toxic encephalopathies and encephalitis Alongside scalp EEG intracranial recordings have been developed to optimize the localization of epileptic activity with a view to epilepsy surgery
Two main categories of intracranial electrodes are currently in use
1 StereoElectroEncephalopGraphy electrodes consist of a stylus with a string of cylindrical contacts along its length implanted directly into the brain parenchyma
2 ElectroCorticoGraphy ECoG electrodes non-penetrating organized in strips or grids of 4 to 64 electrodes disc-shaped 02 to 1 cm in diameter 05 to 1 mm thick used to collect cerebral activity at the cortical surface
Among its indication surgery is a favorable circumstance for using ECoG During brain surgery cortical exposure enables cortical EEG recording without additional invasiveness Intraoperative ECoG is of particular interest in epilepsy surgery recently reactivated by the discovery of better electrophysiological biomarkers In glioma surgery often performed under awake conditions cortical recording helps to establish a functional cerebral map and to adapt the resection Indeed ECoG recordings can be performed during awake surgery without any disturbance of neuronal activity by anesthesia to map epileptic activity using visual identification of spikes and to look for seizures induced by electrical stimulation The evolution of these recording techniques is moving towards the development of tools for automatic analysis and mapping of new biomarkers more relevant but more difficult to record because they are more focal and characterized by amplitudes close to background noise such as high-frequency oscillations New types of cortical electrodes are being developed to improve the spatial resolution better localization temporal resolution faster activity detection and detection sensitivity signal-to-noise ratio of cortical electrical signals
New electrodes have recently been developed based on the use of conductive organic polymer coatings such as poly34-ethylenedioxythiophene PEDOT PSS to optimize the signal-to-noise ratio organized in electrode arrays that are 100 times thinner 5 microns vs 05 mm for standard electrodes 250 times smaller between 30 and 500 microns vs 8 mm for standard electrodes and with more electrodes 128 vs 6 or 8 for standard electrodes This type of electrode known as microECoG has been validated in animals and has already been used in human research for intraoperative cortical recordings They enable us to improve the quality of the recorded signal and to go down to a new scale at the level of the neuron Moreover the very low thickness of the electrodes improves their conformability to the cortex making them much more tolerable and enabling extended recordings to be envisaged as part of future manmachine interfaces
The French company Panaxium is developing microECoG electrodes As part of a collaborative project Panaxium have designed a 4x2 cm 6 micron-thick electrode comprising 128 electrodes 28 500 µm electrodes 96 30 µm diameter microelectrodes organized as tetrodes and 4 reference electrodes for clinical use in humans The aim of this study is to explore the safety and quality of signals collected by the Panaxium microECoG during awake surgery for brain gliomas Recording will be carried out using a high-performance EEG system CE-marked for medical use in humans
The electrode will be placed on the cortical surface and repositioned every 90 seconds to sample the entire exposed brain surface During the cortical electrical stimulation mapping phase the electrode will be left at the edge of the field to detect epileptic discharges induced by stimulation After resection a new recording of the residual cortical surface will be made to check for persistent electrical anomalies The surgeries and recordings will be carried out in 3 centers by neurosurgeons with expertise in brain tumors and awake surgery Hôpital Sainte-AnneGHU Paris Hôpital Pietié-Salpêtrière Hopital Fondation Adolphe de Rostschild In the last 10 patients the Panaxium microECoG will be compared with a macro-electrode for clinical use
The primary endpoint will be the incidence of Serious Adverse Events due to the use of Panaxium microelectrodes during surgery and the following four days cortical lesion by the electrode infection bleeding aseptic meningitis neurological deficit due to the use of the electrode death Secondary evaluation criteria will be the quality of recordings enabled by the Panaxium microECoG signal-to-noise ratio reflecting signal quality electrode impedance during surgery reflecting technical quality detection of fast ripple 100-250 Hz and fast ripple 250-600 Hz oscillations only possible with high-performance recorders ability to record spontaneous epileptic activity spikes and equivalent or direct post-electrical stimulation post-discharges and practicality of use as perceived by neurosurgeons Finally as an exploratory study for future uses of these electrodes we will investigate their ability to record multi-unit activity action potentials from single neurons and the correlation between recorded activity and tumor infiltration as well as local oncometabolite concentration
Two main categories of intracranial electrodes are currently in use
1 StereoElectroEncephalopGraphy electrodes consist of a stylus with a string of cylindrical contacts along its length implanted directly into the brain parenchyma
2 ElectroCorticoGraphy ECoG electrodes non-penetrating organized in strips or grids of 4 to 64 electrodes disc-shaped 02 to 1 cm in diameter 05 to 1 mm thick used to collect cerebral activity at the cortical surface
Among its indication surgery is a favorable circumstance for using ECoG During brain surgery cortical exposure enables cortical EEG recording without additional invasiveness Intraoperative ECoG is of particular interest in epilepsy surgery recently reactivated by the discovery of better electrophysiological biomarkers In glioma surgery often performed under awake conditions cortical recording helps to establish a functional cerebral map and to adapt the resection Indeed ECoG recordings can be performed during awake surgery without any disturbance of neuronal activity by anesthesia to map epileptic activity using visual identification of spikes and to look for seizures induced by electrical stimulation The evolution of these recording techniques is moving towards the development of tools for automatic analysis and mapping of new biomarkers more relevant but more difficult to record because they are more focal and characterized by amplitudes close to background noise such as high-frequency oscillations New types of cortical electrodes are being developed to improve the spatial resolution better localization temporal resolution faster activity detection and detection sensitivity signal-to-noise ratio of cortical electrical signals
New electrodes have recently been developed based on the use of conductive organic polymer coatings such as poly34-ethylenedioxythiophene PEDOT PSS to optimize the signal-to-noise ratio organized in electrode arrays that are 100 times thinner 5 microns vs 05 mm for standard electrodes 250 times smaller between 30 and 500 microns vs 8 mm for standard electrodes and with more electrodes 128 vs 6 or 8 for standard electrodes This type of electrode known as microECoG has been validated in animals and has already been used in human research for intraoperative cortical recordings They enable us to improve the quality of the recorded signal and to go down to a new scale at the level of the neuron Moreover the very low thickness of the electrodes improves their conformability to the cortex making them much more tolerable and enabling extended recordings to be envisaged as part of future manmachine interfaces
The French company Panaxium is developing microECoG electrodes As part of a collaborative project Panaxium have designed a 4x2 cm 6 micron-thick electrode comprising 128 electrodes 28 500 µm electrodes 96 30 µm diameter microelectrodes organized as tetrodes and 4 reference electrodes for clinical use in humans The aim of this study is to explore the safety and quality of signals collected by the Panaxium microECoG during awake surgery for brain gliomas Recording will be carried out using a high-performance EEG system CE-marked for medical use in humans
The electrode will be placed on the cortical surface and repositioned every 90 seconds to sample the entire exposed brain surface During the cortical electrical stimulation mapping phase the electrode will be left at the edge of the field to detect epileptic discharges induced by stimulation After resection a new recording of the residual cortical surface will be made to check for persistent electrical anomalies The surgeries and recordings will be carried out in 3 centers by neurosurgeons with expertise in brain tumors and awake surgery Hôpital Sainte-AnneGHU Paris Hôpital Pietié-Salpêtrière Hopital Fondation Adolphe de Rostschild In the last 10 patients the Panaxium microECoG will be compared with a macro-electrode for clinical use
The primary endpoint will be the incidence of Serious Adverse Events due to the use of Panaxium microelectrodes during surgery and the following four days cortical lesion by the electrode infection bleeding aseptic meningitis neurological deficit due to the use of the electrode death Secondary evaluation criteria will be the quality of recordings enabled by the Panaxium microECoG signal-to-noise ratio reflecting signal quality electrode impedance during surgery reflecting technical quality detection of fast ripple 100-250 Hz and fast ripple 250-600 Hz oscillations only possible with high-performance recorders ability to record spontaneous epileptic activity spikes and equivalent or direct post-electrical stimulation post-discharges and practicality of use as perceived by neurosurgeons Finally as an exploratory study for future uses of these electrodes we will investigate their ability to record multi-unit activity action potentials from single neurons and the correlation between recorded activity and tumor infiltration as well as local oncometabolite concentration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None