Synchron, Inc.
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
The Synchron BCI motor neuroprosthesis is an implanted brain-computer interface indicated for individuals with bilateral upper-limb motor impairment, such as Amyotrophic Lateral Sclerosis (ALS). The Synchron BCI is intended to replace the function of motor neurons by detecting, translating and transmitting motor-related brain signals to restore clinically meaningful control of digital devices.
Inclusion Criteria: * Able to provide informed consent to participate in the study. * Diagnosis of ALS, with bilateral upper-limb paresis. * ALS must be refractory to treatment and have been present for a minimum of six months. * Aged 22 years or older. * Life expectancy greater than 12 months post-implantation. * Preserved precentral gyrus assessed using CT. * Suitable vascular anatomy assessed using CT venography. * Suitable anatomy for subcutaneous pocket creation. * Able to undergo anesthesia. * Willing and able to comply with all investigational requirements, including clinical testing v…
The Stentrode is an endovascular electrode array that senses electrical signals from the sensorimotor cortices.
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