Tests new micro brain-recording electrodes during awake glioma surgery
Tests new micro electrodes that record brain signals in adults with glioma during awake surgery.
Plain-language title generated from the registry record
Registry title: Glioma Intraoperative MicroElectroCorticoGraphy
Key facts
- Where
- Paris, FranceSee the 3 sites
Where in France
- Centre Hospitalier Sainte-AnneParis, FranceNo longer taking part
- Hopital Fondation Adolphe de RothschildParis, FranceNo longer taking part
- Hopital Pitie-SalpetriereParis, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut National de la Santé Et de la Recherche Médicale, France
- Trial code
- NCT06408428
- Record updated
- 12 March 2025
- Original description
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:Read full original descriptionShow less
Glioma Intraoperative MicroElectroCorticoGraphy
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.
Inclusion: 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: Current treatment with antibiotics; 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; Acute or untreated infection (viral, bacterial or fungal); Pregnant or breast-feeding women; Other pathologies that could interfere with the neurological evaluation or compromise the subject's safety; Adult subject to legal protection.