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Chronic speech BCI

University Hospital, Grenoble • Sclérose latérale amyotrophique

Suivi actif Non applicable

Résumé

Chronic speech BCI est développé par University Hospital, Grenoble. Le traitement est actuellement en Non applicable. Il est associé à Sclérose latérale amyotrophique. Son objectif thérapeutique principal est À vérifier. Le statut actuel est : suivi actif.

À vérifier

À vérifier
Non applicable
University Hospital, Grenoble
France
Eighteen million people worldwide are affected by speech disorders. Locked-in syndrome (LIS) represents the most extreme form of communication disability resulting from motor impairment. In France, the Association du Locked-In Syndrome (ALIS) reports approximately 500 individuals with LIS, most of whom live at home. The quality of life of people with LIS depends strongly on their ability to communicate, and speech synthesis is the mode of communication restoration most desired by individuals with LIS. Several surveys have shown that improving communication abilities in these individuals leads to a significant improvement in their quality of life as well as that of their caregivers. Natural speech allows the production of an average of 150 words per minute. Non-invasive communication methods, whether based on residual motor function (eye-blink code) or on brain-machine or brain-computer interfaces (Brain-Computer Interface, BCI) using scalp electroencephalographic (EEG) signals, involve a high cognitive load and have low efficiency (spelling only a few letters per minute). Invasive BCIs for speech rehabilitation aim to overcome the limitations of non-invasive devices (cognitive overload and slow speech rate). The intention to act (the act of speaking) is predicted by an algorithm based on the direct decoding of neuronal activity from the sensorimotor cortex (the area where articulatory muscles are represented). To date, studies testing speech rehabilitation BCIs in humans remain rare. A subdural electrocorticographic (ECoG) invasive BCI enabled speech decoding (words and sentences from a limited repertoire) for chronic use (2 years). Real-time control of an on-screen cursor allowing spelling of up to 90 letters per minute (equivalent to text messaging) has also been achieved using an intracortical invasive BCI (Utah Array). Very recently, up to 60 words per minute were produced using an intracortical invasive BCI (Utah Array) implanted in the ventral premotor cortex, although with a connector potentially contaminated by acoustic audio feedback. Furthermore, these devices still rely on transcutaneous connectors, which may be sources of infection and prevent routine daily-life use. In summary, there is currently no fully implantable, wireless invasive "speech BCI" with real-time speech synthesis suitable for long-term home use. The present study will use an intracranial extradural invasive BCI combined with a speech synthesizer, with the aim of developing a communication tool suitable for everyday use. More specifically, the SpeechBCI protocol will propose two complementary BCI approaches in the same subject: a speech BCI (primary objective, BCI\_PAROLE device) and a cursor BCI (secondary objective). Both BCIs will use the WIMAGINE intracranial epidural system, enabling ECoG signal acquisition with a very limited risk of infection and brain injury and providing signals that are more stable over time compared with intracortical or subdural ECoG devices that retain transcutaneous connectors. These systems will allow long-term and ecological use, as the WIMAGINE implant is wireless and offers excellent long-term signal stability. The WIMAGINE implant has already been successfully tested for controlling an exoskeleton in a tetraplegic subject (operational for over 6 years) and very recently for controlling walking in real-life conditions via a spinal cord stimulator in a paraplegic individual. The BCI\_PAROLE device will integrate a speech synthesizer providing real-time auditory feedback to the speaker. The BCI-CURSEUR device will allow the subject to control an on-screen cursor to access various communication functionalities (web access, emails, chats, etc.). This will provide a complementary communication solution to real-time speech production. The hypothesis of this stydy is that the intention to speak (attempted speech) will be decoded by the BCI\_PAROLE device in individuals with LIS because, as with limb paralysis, paralysis of articulatory and phonatory muscles does not prevent the corresponding cortical map from producing specific signals. Similarly, the BCI-CURSEUR device will decode the intention to move a cursor and perform actions on a computer screen. Neuronal electrical signals will be recorded bilaterally from the ventral motor cortex (representation of lips, cheeks, tongue, palate, and larynx-the vocal tract) and from the dorsal part of the motor cortex (larynx and hand, the latter for controlling a two-degree-of-freedom cursor), using a total of 128 electrodes (64 on each cerebral hemisphere). The implant will be optimally positioned over speech motor areas using preoperative functional imaging in order to optimize speech decoding by the BCI\_PAROLE device.
2026-07-07

Début phase actuelle
Non disponible dans les sources synchronisées
Timeline clinique

Non applicable
Préclinique
Phase 1
Phase 2
Phase 3
Approuvé

Objectif scientifique de l’étude

classification automatique vérifiable
À vérifier Confiance automatique : 0%
Contrôle de cohérence : 85/100

L’objectif est absent ou classé « Autre » et doit être recalculé à partir du protocole.

Transparence et qualité de la fiche

données vérifiables
ClassificationÀ vérifier
Confiance de la fiche85 %
Source principaleSource officielle ou publication indexée
Dernière vérification2026-07-07
Anomalies détectées1
Validation humaineValidation humaine non effectuée
Donnée issue d’une source Donnée normalisée automatiquement Interprétation algorithmique

Classification scientifique multi-axes

ne pas confondre statut et résultat
État de l’étudeStatut inconnu
Disponibilité des résultatsRésultats à vérifier
InterprétationImpossible à déterminer
Niveau de preuveNon évaluable

Un essai terminé n’est pas nécessairement positif. Un essai arrêté n’est classé comme échec scientifique que lorsqu’un résultat ou une raison explicite le confirme.

Indicateurs factuels

sans score subjectif
Phase enregistréeNon applicable
Études associées1
Publications associées3
Statut consolidéSuivi actif

Aucune chance de succès, note d’innovation, potentiel thérapeutique ou probabilité de commercialisation n’est calculé tant qu’un modèle validé et des données suffisantes ne sont pas disponibles.

Historique factuel de la molécule

7 événement(s) daté(s)

Cette liste reprend uniquement les dates trouvées dans les registres et publications liés. Elle ne constitue pas une prévision.

DateÉvénementSource
2026-07-07Dernière mise à jour des donnéesChronic speech BCIBiomedical Watch
2026-08-13Création de l’enregistrementNCT07698496Registre d’essai clinique
2026-08-16PublicationInitial experience with the precision neuroscience Layer 7 micro-electrocorticography interface for real-time intraoperative neural decoding.Neurosurgical focus
2026-08-16PublicationBeyond the Air-Bone Gap: The Role of Bone Conduction Thresholds in Predicting Functional Outcomes and Guiding Surgical Decision-Making in Active Middle Ear and Bone Conduction Implants.Audiology research
2026-08-16PublicationManagement of conductive and mixed hearing loss intolerant to air-conduction hearing aids: A stepwise algorithm and narrative review from a Japanese perspective.Auris, nasus, larynx
2026-10-10Début de l’étudeNCT07698496Registre d’essai clinique
2031-09-30Fin de l’étude prévue / enregistréeNCT07698496Registre d’essai clinique

Début phase actuelle
Non disponible dans les sources synchronisées
Essais cliniques liés

1 essai(s)
NCT Titre Phase Statut administratif Pays Sponsor
NCT07698496 SpeechBCI — Evaluation of the Feasibility and Efficacy of a Chronic Brain-computer Interface for Speech Rehabilitation in Patients With Locked-in-syndrome (LIS) Non applicable NOT_YET_RECRUITING France University Hospital, Grenoble

Publications liées

3 publication(s)

Publications liées

3 publication(s)
Titre PMID DOI Journal Date
Initial experience with the precision neuroscience Layer 7 micro-electrocorticography interface for real-time intraoperative neural decoding. Voir source 41621103 10.3171/2025.11.FOCUS25908 Neurosurgical focus
Beyond the Air-Bone Gap: The Role of Bone Conduction Thresholds in Predicting Functional Outcomes and Guiding Surgical Decision-Making in Active Middle Ear and Bone Conduction Implants. Voir source 41874079 10.3390/audiolres16020046 Audiology research
Management of conductive and mixed hearing loss intolerant to air-conduction hearing aids: A stepwise algorithm and narrative review from a Japanese perspective. Voir source 42259065 10.1016/j.anl.2026.05.001 Auris, nasus, larynx

Sources officielles

liens de recherche
ClinicalTrials.gov PubMed EMA FDA CTIS

Dernière mise à jour des données : 2026-07-07

Ces sources sont proposées pour vérification. Les informations de la fiche doivent être confirmées dans les registres officiels ou les publications originales.

Biomedical Watch © 2026

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Version : V150 Études : 3 024 Traitements : 3 427 Sociétés : 1 338 Centres : 36 292 Dernière synchronisation : 14 septembre 2026 15:37 Base mise à jour : 14 septembre 2026
Les synthèses, badges et classifications sont une aide à la lecture. Elles ne remplacent ni les registres officiels, ni les publications originales, ni l’avis d’un professionnel de santé.