Glioma Intraoperative MicroElectroCorticoGraphy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Safety of PEDOT:PSS microECoGs use
研究概览
简要总结
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.
详细描述
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.
- StereoElectroEncephalopGraphy electrodes consist of a stylus with a string of cylindrical contacts along its length, implanted directly into the brain parenchyma.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Glioma Surgery - MicroECoG recording
干预措施: PANAXIUM MicroECoG (Device)
结局指标
主要结局
Safety of PEDOT:PSS microECoGs use
时间窗: 30 months
Assessment of the safety of PEDOT:PSS microECoGs use by assessing the rate of serious adverse events associated with their use during glioma surgery
次要结局
- Quality of PEDOT:PSS microECoGs recordings(30 months)
- Practicality of microelectrodes use as perceived by neurosurgeons.(30 months)
