Placement of high-density electrodes on cortical surface during awake surgeryPlacement of INBRAIN Graphene Cortical Interface on cortical surfacePlacement of low-density electodes during awake brain surgery
Placement of high-density electrodes on cortical surface during awake surgery: INBRAIN Graphene Cortical Interface (Non-CE-marked Class III )high-density graphene ECoG grid placed on cortical surface for up to 2 hours during awake surgery. Recording only, no stimulation.
Placement of INBRAIN Graphene Cortical Interface on cortical surface: INBRAIN Graphene Cortical Interface (Non-CE-marked Class III )high-density graphene ECoG grid placed on cortical surface for up to 2 hours during awake brain surgery. Recording only, no stimulation.
Placement of low-density electodes during awake brain surgery: DIXI C10-12BIOM and WISE WCS00-4S10-000 (CE-marked Class III) low-density ECoG strips placed on cortical surface for up to 2 hours during awake surgery. Recording only, no stimulation.
Study summary
The clinical investigation evaluates whether speech can be decoded from neural activity recorded with cortical surface electrocorticography (ECoG) electrodes during awake brain tumor surgery. Neural signals and voice recordings are collected while patients perform a picture naming task as part of standard intraoperative mapping. The study assesses the ability of machine learning algorithms to predict the named item from intraoperative electrophysiological recordings.
Eligibility
Sex
ALL
Min age
18 Years
Max age
84 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients 18 years of age or older.
2. Patients with a brain tumor requiring surgery under "awake" conditions with intraoperative placement of ECoG electrodes at Lariboisière Hospital.
3 -Patients with tumor locations close to language processing areas. 4 -Patients having given consent during the interview with the neurosurgeon.
Exclusion Criteria:
1. Patients with severe cognitive impairments that would prevent understanding and performing the image-naming task,
2. Patients with major psychiatric disorders that could affect their ability to participate in the research,
3. Patients with inoperable tumors,
4. Patients with tumor locations incompatible with safe or effective placement of ECoG electrodes,
5. Females that are breastfeeding or females with childbearing potential with positive urine pregnancy test or not using adequate contraception,
6. Patients unable to provide informed consent due to cognitive or language limitations,
7. Patients who have any electrical stimulator or any active implanted medical device that uses high magnetic or electrical currents (e.g. patients with pacemaker defibrillator, neurostimulator, drugs pumps, retinal and cochlear device),
8. Any wearable medical device that may cause troubles to the investigational devices and injuries to the participants,
9. Patients with medical contraindications to general or local anesthesia required for surgery,
10. Patients with an active infection or infectious skin lesions on the scalp,
11. Patients with a current use or a recent history of illicit drug(s) use or alcohol abuse (defined as frequent or daily consumption of more than four alcoholic drinks per day),
12. Patients with contraindications to any surgical procedure,
13. Patients undergoing treatment with anticoagulants, platelet aggregation inhibitors, or non-steroidal anti-inflammatory drugs,
14. Patients who decline to participate in the study,
15. Any specially protected person: adults protected by law; persons hospitalized without their consent, at the request of a third party or ex officio; persons deprived of their liberty by a judicial decision,
16. Participation in another interventional study or being in the exclusion period at the end of a previous study.
Primary outcome measure(s)
Primary outcome Measure — Up to 12 months after the last patient's intraoperative recording The primary metric for evaluating the success of the project is the accuracy of the machine learning algorithms in decoding neural activity to predict the named item by the patient. Achieving an Area Under the Curve (AUC) value of greater than 0.9 indicates high predictive performance.
Trial sites (1)
Facility
City
Region
Status
Department of neurosurgery Lariboisière hospital-APHP
Paris
Île-de-France Region
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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