Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07499479

Picture Naming Decoding From Intraoperative Recordings

Picture Naming Decoding From Intraoperative Electrophysiological Recordings During Awake Brain Tumor Surgery.

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years – 84 Years
Healthy volunteers
Not accepted

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.

Detailed description

Patients with severe speech and motor impairments often lose the ability to communicate, detrimentally affecting their quality of life. Invasive brain-computer interfaces (BCIs) have shown promise in restoring lost speech functionalities by decoding neural activity of intended or attempted speech. However, the systems with the most promising results rely on highly invasive micro-electrode arrays that tend to irritate the brain tissue leading to inflammation, tissue scarring and ultimately, loss of signal. A promising long-term alternative is intracranial electrode strips/grids that rest on the surface of the brain without having to penetrate the cortex. The contact density of standard strips/grids used for electrophysiological mapping is very low (1 contact/cm2 compared to 100 contacts/cm2), however, a new generation of electrode strips/grids offer decent contact density closing the distance with micro-electrode arrays. In order to determine if the contact density of cortical surface electrode grids is sufficient for decoding speech, we aim to record and decode neural activity of tumor patients performing a picture naming task during awake surgeries, as these operations offer the only opportunity to test the use of cortical surface electrodes for neural speech decoding.

Conditions

Interventions

TypeNameDescription
PROCEDUREPlacement of high-density electrodes on cortical surface during awake surgeryINBRAIN 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.
PROCEDUREPlacement of INBRAIN Graphene Cortical Interface on cortical surfaceINBRAIN 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.
PROCEDUREPlacement of low-density electodes during awake brain surgeryDIXI 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.

Timeline

Start date
2026-04-15
Primary completion
2029-10-15
Completion
2030-10-15
First posted
2026-03-30
Last updated
2026-03-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07499479. Inclusion in this directory is not an endorsement.