Early Feasibility Study of the Synchron BCI Motor Neuroprosthesis Stentrode for Adults with ALS and Bilateral Upper-Limb Paralysis

What this Trial Is About

Researchers are evaluating the Synchron BCI motor neuroprosthesis, an implanted brain-computer interface designed for people with bilateral upper-limb motor impairment, such as those caused by Amyotrophic Lateral Sclerosis ALS. The device aims to replace motor neuron function by detecting and transmitting brain signals to help users control digital devices. This early feasibility study focuses on understanding the safety and potential of this technology for individuals with ALS and related motor neuron diseases. The study involves implanting the Stentrode device, an endovascular electrode array that senses electrical signals from the brains sensorimotor areas. Participants receive this implant and are then monitored over time. The study includes a single treatment arm where the device is implanted, followed by assessments at various time points up to one year post-implantation to evaluate device safety and function. Participants will be involved in clinical testing visits and training both at the study site and in their homes, supported by caregivers. Researchers will track serious adverse events related to the device up to one year after implantation. Imaging tests such as CT venography will assess the blood vessel condition and device position at six months and one year. The study duration and follow-up involve regular evaluations to monitor safety and device performance.

INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study