Glioma Intraoperative MicroElectroCorticoGraphy

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Study ID
NCT06408428
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PANAXIUM MicroECoG — DEVICE
    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.

Study Details

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.

Key Dates

First listed
May 10, 2024
Start date
Sep 30, 2025
Status verified
Mar 2025
Primary completion
Sep 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Glioma Surgery - MicroECoG recording

Primary Outcome Measure

Safety of PEDOT:PSS microECoGs use [ Time Frame: 30 months ]

Central Contacts

Find similar trials

Nationwide
Epilepsy trialsBrain cancer trialsNeurology trialsBrain disorders trialsOncology trialsNeuro-oncology trials

Related Studies