Glioma Intraoperative MicroElectroCorticoGraphy

NCT06408428 | Not Yet Recruiting DMC

• 1 other identifier: C20-90
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Glioma; Epilepsy

Keywords

Glioma surgery; Awake surgery; MicroElectroCorticoGraphy; EEG

Outcome Measures

Primary Outcomes (1)

• Safety of PEDOT:PSS microECoGs use

  Assessment of the safety of PEDOT:PSS microECoGs use by assessing the rate of serious adverse events associated with their use during glioma surgery

  30 months

Secondary Outcomes (2)

• Quality of PEDOT:PSS microECoGs recordings

  30 months

• Practicality of microelectrodes use as perceived by neurosurgeons.

  30 months

Other Outcomes (1)

• ability to record multi-unit activity, correlation between microECoG activity and tumor infiltration - local oncometabolite concentrations, determination of epileptic seizure rate during electrode use

  30 months

Study Arms (1)

Glioma Surgery - MicroECoG recording

EXPERIMENTAL

Device: PANAXIUM MicroECoG

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.

Glioma Surgery - MicroECoG recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Adult subject to legal protection

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• PANAXIUM: collaborator

Study Sites (3)

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Glioma; Epilepsy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Gilles Huberfeld, MD, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles Huberfeld, MD, PhD

CONTACT

+331 40 78 92 87; gilles.huberfeld@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: May 10, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)