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 range
22 Years – 75 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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