Trial Title:
Glioma Intraoperative MicroElectroCorticoGraphy
NCT ID:
NCT06408428
Condition:
Glioma
Epilepsy
Conditions: Official terms:
Glioma
Conditions: Keywords:
Glioma surgery
Awake surgery
MicroElectroCorticoGraphy
EEG
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Device Feasibility
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
PANAXIUM MicroECoG
Description:
The PANAXIUM microelectrode ( 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) 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. In
the last 10 patients, the Panaxium microECoG will be compared with a macro-electrode for
clinical use.
Arm group label:
Glioma Surgery - MicroECoG recording
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 (PEDOT:PSS) in patients suffering
of gliomas during resection surgery performed in awake condition. The main questions it
aims to answer are:
- Safety of PEDOT:PSS microECoGs by assessing the rate of serious adverse events
associated with their use during glioma surgery.
- Quality of PEDOT:PSS 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, 0.2 to 1 cm in diameter, 0.5 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 poly(3,4-ethylenedioxythiophene (PEDOT: PSS), to optimize the
signal-to-noise ratio, organized in electrode arrays that are 100 times thinner (5
microns vs. 0.5 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 man/machine
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-Anne/GHU 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients suffering of a diffuse cerebral glioma for which surgical resection is
indicated.
- Planned awake surgery with intraoperative functional mapping.
- Planned surgery with ECoG electrophysiological monitoring.
- Age greater than or equal to 18 years.
- Enrolled in a social security scheme, Couverture Médicale Universelle (CMU) or
equivalent.
- Have given written consent.
Exclusion Criteria:
- Acute or untreated infection (viral, bacterial or fungal).
- Current treatment with antibiotics.
- Pregnant or breast-feeding women.
- Other pathologies that could interfere with the neurological evaluation or
compromise the subject's safety.
- Participation in therapeutic biomedical research that could modify the lesion or its
environment during the study period (whether by drug or medical device) or subject
to an exclusion period for other research.
- Adult subject to legal protection
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Pitié Salpêtrière
Address:
City:
Paris
Zip:
75013
Country:
France
Contact:
Last name:
Bertrand MATHON, PhD
Investigator:
Last name:
Bertrand MATHON, PhD
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Sainte-Anne
Address:
City:
Paris
Zip:
75014
Country:
France
Contact:
Last name:
Johan PALLUD, PhD
Email:
J.PALLUD@ghu-paris.fr
Investigator:
Last name:
Johan PALLUD, PhD
Email:
Principal Investigator
Facility:
Name:
Hôpital Fondation Adolphe de Rothschild
Address:
City:
Paris
Zip:
75019
Country:
France
Contact:
Last name:
Gilles HUBERFELD, PhD
Email:
ghuberfeld@for.paris
Investigator:
Last name:
Gilles HUBERFELD, PhD
Email:
Principal Investigator
Start date:
September 2024
Completion date:
October 2026
Lead sponsor:
Agency:
Institut National de la Santé Et de la Recherche Médicale, France
Agency class:
Other
Collaborator:
Agency:
PANAXIUM
Agency class:
Other
Source:
Institut National de la Santé Et de la Recherche Médicale, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06408428
