Clinical trial · Interventional
Glioma Intraoperative MicroElectroCorticoGraphy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epilepsy | — | UNRESOLVED | — |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PANAXIUM MicroECoG | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Glioma Surgery - MicroECoG recording
- interventionNames
- Device: PANAXIUM MicroECoG
Primary outcomes (1)
- measure
- Safety of PEDOT:PSS microECoGs use
- timeFrame
- 30 months
- description
- Assessment of the safety of PEDOT:PSS microECoGs use by assessing the rate of serious adverse events associated with their use during glioma surgery
Secondary outcomes (2)
- measure
- Quality of PEDOT:PSS microECoGs recordings
- timeFrame
- 30 months
- description
- Quality of PEDOT:PSS microECoGs recordings assessment 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available