Picture Naming Decoding From Intraoperative Recordings

ConditionBrain Tumor Adult

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-84

SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

Placement of high-density electrodes on cortical surface during awake surgery
Procedure/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
Procedure/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 brain surgery. Recording only, no stimulation.
Placement of low-density electodes during awake brain surgery
Procedure/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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: INBRAIN Graphene Cortical Interface (Non-CE-marked Class III )Experimental treatment 2 interventions

Group B: DIXI C10-12BIOM and WISE WCS00-4S10-000 (CE-marked Class III)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

Secondary Outcome Measure

The evaluation criterion is to identify axono-cortical evoked potentials (ACEPs) with a signal- to-noise ratio \> 1. The parameters consist of all recordings made by surface electrodes during axonal electrical stimulation at 1 Hz. On each channel, averaging will be performed, synchronized with the 1 Hz stimulation.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: