Functional Outcomes and Control Using Synchron BCI - Australia (FOCUS-AUS)
Able to provide informed consent to participate in the study.
Bilateral upper-limb paresis or Amyotrophic lateral sclerosis (ALS) with bilateral upper limb paresis
The underlying condition causing motor impairment must be refractory to treatment and have been present for a minimum of twelve months.
Aged 21 years or older
Unrealistic expectations regarding the potential benefits of the device.
Active infection or unexplained fever in the 48 hours prior to informed consent
Major psychiatric disorder that may adversely impact the participant's safety or study compliance, including severe depression, psychotic features, personality disorder, severe emotional lability, or substance abuse.
Dementia or cognitive dysfunction that would impact the participant's ability to participate in study activities.
Single group
Stentrode
DeviceThe Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.
Device-related serious adverse events resulting in death or permanently increased disability up to 90 days after implant.
Device-related serious adverse events resulting in death or permanently increased disability up to 1 year after implant.
Target vessel patency assessed using CT venography at 90 days and 365 days after implant
Device migration assessed using CT imaging at 90 days and 365 days after implant
Time in days from implant to device activation
Stability of recorded Synchron BCI signal up to 1 year after device implant
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