Brain-Computer Interface Implant for Severe Communication Disability (NCT04576650) | Clinical Trial Compass
WithdrawnNot Applicable
Brain-Computer Interface Implant for Severe Communication Disability
Stopped: Investigational device no longer available. No subjects enrolled.
United States0Started 2022-10
Plain-language summary
Locked-In Syndrome (LIS) is a devastating condition in which a person has lost the ability to communicate due to motor impairment, while being mentally intact. For people affected by this severe communication impairment, Brain-Computer Interfaces (BCI) may be the only solution that allows these people to start a conversation, ask questions, or request assistance (i.e. self-initiated communication). To-date, spelling was accomplished at a rate of 2-3 letters per minute with a predecessor device (the Medtronic Activa PC+S). To improve BCI performance, the current protocol will use the Medtronic Summit System, which offers a rechargeable battery and improved signal quality relative to Activa PC+S. Using signals from the motor hand/arm and/or motor mouth/face area, the investigators will investigate different avenues to improve the speed of communication using the Summit System. The primary objective is to evaluate the safety of the Summit System when used to chronically record subdural electrocorticographic (ECoG) signals in a BCI for use by patients with LIS in patients' homes. The secondary objective will be to evaluate the efficacy of the Summit System as a long-term source of ECoG signals for a BCI capable of allowing participants to control alternative and augmentative communication software in patients' homes.
Who can participate
Age range22 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age between 22-75 years.
Exclusion criteria
✕. Clinical diagnosis of, and confirmatory/exclusionary testing consistent with, one of the following irreversible or progressive neurological disorders as the cause for chronic Locked-In Syndrome, as defined above:
✕. Electrophysiological Studies
✕. Electromyographic findings of denervation (reduced recruitment, large motor unit action potentials, and fibrillation potentials) in clinically involved regions, including 3 of the following 4 muscle regions: bulbar, cervical, thoracic, and lumbosacral
✕. Nerve conduction studies confirming absence of demyelination as an explanation for aforementioned LMN signs
✕. Neuroimaging, including brain and spine MRI, ruling out brain or spinal lesions (spinal cord or root compression) that could explain aforementioned LMN or UMN signs
✕. Clinical laboratory examinations, determined by clinical judgment, to ascertain possible ALS-related syndromes v. History, physical, and laboratory examinations ruling out alternative diagnoses as cause of aforementioned clinical syndrome, including monoclonal gammopathy, autoimmune motor system degeneration, hyperthyroidism, hyperparathyroidism, paraneoplastic syndrome, infections of the central nervous system, toxic-metabolic disorders, or spinal cord injury due to trauma, electric shock, radiation therapy, vasculitis, ischemia, hemorrhage, or spondylotic myelopathy vi. No clinical evidence for improving communication ability for at least 6 months, confirming chronic LIS
What they're measuring
1
Safety of Summit System as assessed by the number of adverse events
Timeframe: Up to 52 weeks
2
Safety of Summit System as assessed by change in neurological deficits
Timeframe: Immediately before device implantation, immediately after device implantation and 4-5 weeks after device implantation
3
Safety of Summit System as assessed by the status of stimulation
✕. Reliable means of communicating with caregiver(s) before entering the study, for example using vertical eye movements or eye blinking. Assessment of communication capabilities may be made by a physiatrist, a speech therapist, and/or an occupational therapist.
✕. Residence within a reasonable driving distance from the JHU research team