NCT07698496
Evaluation of the Feasibility and Efficacy of a Chronic Brain-computer Interface for Speech Rehabilitation in Patients With Locked-in-syndrome (LIS)
Not Yet Recruiting · Not Applicable · University Hospital, Grenoble · registry updated 2026-07-13
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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)....
Inclusion
- a. Male or female between 18 and 65 years old b. French speaking person c. Person in locked in syndrome with a severe speech disorder following either: i. A subcortical stroke ii. Amyotrophic Lateral Sclerosis. d. Person with stable clinical state (esp. regarding respiratory state) e. Person able to read on a screen (sufficient eye movement control) f. Negative plasma pregnancy test for women of childbearing potential\* g. Highly effective or at least acceptable\*\* contraception for women of childbearing potential.
- h. Persistence of localizing signals of language function proven by functional MRI.
- i. Person able to perform a simple BCI task with MEG j. Person with a neuropsychological profile evaluated by psychiatrist as compatible with sustain BCI training k. Informed consent to participate in the obtained using their usual means and code of communication (residual vocalizations, eye-blinking code, pictograms, eye tracking, alphabet chart, etc.), in the presence of their trusted person or curator who is accustomed to communicating with them using this means.
- l. Person affiliated to the French social security system or beneficiary of such a system
Exclusion
- Patients with any of the following criteria cannot be included in this investigation:
- Severe cognitive disorders assessed after a neuropsychological evaluation
- Continuous assisted ventilation
- Contraindication to intracranial surgery
- Contra-indication to MRI (1.5T), CT-scan or their related contrast agent injection or MEG examinations.
- Anatomical brain MRI showing structural abnormalities in the cortical areas of language