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

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 visits and training visits in the home. * Caregiver(s) willing and able to facilitate study visits, including visits to the study site and in the home, and BCI use outside of study visits (e.g., device charging). * Patient and caregiver fluent in English. * Suitable home environment for BCI training. Exclusion Criteria: * 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. * Diagnosis of ALS-FTD or another dementia. * Active implanted device (e.g., deep brain stimulator, cardiac defibrillator, pacemaker, vagal nerve stimulator, spinal cord stimulator, diaphragmatic pacer, etc.). * Known allergy to patient-contacting materials included in the i…