NCT06408428Not yet recruiting
Glioma Intraoperative MicroElectroCorticoGraphy
Source: ClinicalTrials.gov · Last updated 12 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 23 Jan 2024
- Start date
- Sept 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- Epilepsy
- NCT number
- NCT06408428
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Sept 2025 to the primary completion date, Sept 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Acute or untreated infection (viral, bacterial or fungal).
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Fondation Adolphe de Rothschild Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Sainte-Anne Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Pitie-Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.