Long-Term Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis

Abstract

<h3>Research Objectives</h3> This first-in-human study assessed safety of an implanted brain-computer interface (BCI). Secondary objective was feasibility of using the implant as a motor neuron prosthesis (MNP) to control a computer by thought. <h3>Design</h3> First-in-human, single arm, open-label, prospective study with 12-month follow up. <h3>Setting</h3> The implant procedure and follow-up visits were performed at Royal Melbourne Hospital in Australia; training and device usage were performed in clinic and at home with a caregiver present. <h3>Participants</h3> Five subjects were enrolled in the study, and four met the preoperative requirements and received the device implant. Age at enrolment was 61±17 years. All subjects were males with paralysis from amyotrophic lateral sclerosis. Subjects had varying impairment in lung function and speech capability at enrollment. <h3>Interventions</h3> Subjects were implanted with a device (Stentrode, Synchron, Brooklyn, NY) in the largest blood vessel of the brain using venous access. The device was connected to an electronics unit in a subcutaneous pocket that wirelessly communicates through the skin to an external device to allow laptop computer control. <h3>Main Outcome Measures</h3> Primary safety endpoint was device-related serious adverse events resulting in death or permanent increased disability within 12 months after implant. Secondary safety endpoints were target vessel occlusion and incidence of device migration, evaluated 3 and 12 months after implant. The study recorded signal fidelity and stability over 12 months and use of the MNP to perform routine digital tasks. <h3>Results</h3> All four implanted subjects completed the 12-month follow-up with no serious adverse events. Post-operative imaging found no occlusion of the blood vessels or device migration. All implanted subjects successfully used the MNP for computer use in the home. <h3>Conclusions</h3> The study met all safety endpoints, and subjects could use the endovascular MNP to perform digital tasks on a computer. <h3>Author(s) Disclosures</h3> Dr. Oxley is chief executive officer of Synchron and holds stock options and patents on the technology used in the study.