Picture Naming Decoding From Intraoperative Recordings

NCT07499479 | Not Yet Recruiting

• 2 other identifiers: APHP 2506972025-A00931-48
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumor Adult

Outcome Measures

Primary Outcomes (1)

• Primary outcome Measure

  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.

  Up to 12 months after the last patient's intraoperative recording

Secondary Outcomes (1)

• Secondary Outcome Measure

  Up to 12 months after the last patient's intraoperative recording

Study Arms (2)

INBRAIN Graphene Cortical Interface (Non-CE-marked Class III )

EXPERIMENTAL

10 patients receive high-density electrodes.

Procedure: Placement of high-density electrodes on cortical surface during awake surgery; Procedure: Placement of INBRAIN Graphene Cortical Interface on cortical surface

DIXI C10-12BIOM and WISE WCS00-4S10-000 (CE-marked Class III)

ACTIVE COMPARATOR

10 patients receive strandard low-density electrodes.

Procedure: Placement of low-density electodes during awake brain surgery

Interventions

Placement of high-density electrodes on cortical surface during awake surgery PROCEDURE

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.

INBRAIN Graphene Cortical Interface (Non-CE-marked Class III )

Placement of INBRAIN Graphene Cortical Interface on cortical surface PROCEDURE

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.

INBRAIN Graphene Cortical Interface (Non-CE-marked Class III )

Placement of low-density electodes during awake brain surgery PROCEDURE

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.

DIXI C10-12BIOM and WISE WCS00-4S10-000 (CE-marked Class III)

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older.
• Patients with a brain tumor requiring surgery under "awake" conditions with intraoperative placement of ECoG electrodes at Lariboisière Hospital.
• Patients with tumor locations close to language processing areas. 4 -Patients having given consent during the interview with the neurosurgeon.

You may not qualify if:

• Patients with severe cognitive impairments that would prevent understanding and performing the image-naming task,
• Patients with major psychiatric disorders that could affect their ability to participate in the research,
• Patients with inoperable tumors,
• Patients with tumor locations incompatible with safe or effective placement of ECoG electrodes,
• Females that are breastfeeding or females with childbearing potential with positive urine pregnancy test or not using adequate contraception,
• Patients unable to provide informed consent due to cognitive or language limitations,
• 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),
• Any wearable medical device that may cause troubles to the investigational devices and injuries to the participants,
• Patients with medical contraindications to general or local anesthesia required for surgery,
• Patients with an active infection or infectious skin lesions on the scalp,
• 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),
• Patients with contraindications to any surgical procedure,
• Patients undergoing treatment with anticoagulants, platelet aggregation inhibitors, or non-steroidal anti-inflammatory drugs,
• Patients who decline to participate in the study,
• 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,

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of neurosurgery Lariboisière hospital-APHP

Paris, Île-de-France Region, 75010, France

Location

Central Study Contacts

Emmanuel MANDONNET

CONTACT

0149958146; emmanuel.mandonnet@aphp.fr

Anne-Lise GIRAUD

CONTACT

0176535060; anne-lise.giraud-mamessier@pasteur.fr

Study Design

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

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): October 15, 2029
• Study Completion (Estimated): October 15, 2030
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (1)