Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients: The Stentrode With Thought-Controlled Digital Switch Study

OBJECTIVES	To assess the safety of an endovascular brain-computer interface Stentrode (Synchron, Brooklyn, NY, USA) and the feasibility of using the system to control a computer by thought.
STUDY	Single-center, prospective, first-in-human study from May 2019 to June 2021.
POPULATION	5 patients with severe bilateral upper-limb paralysis, 4 patients with amyotrophic lateral sclerosis, and 1 with primary lateral sclerosis.
ENDPOINTS	The primary safety endpoint was device-related serious adverse events resulting in death or permanent increased disability. Secondary endpoints included blood vessel occlusion and device migration. Exploratory endpoints were signal fidelity and stability over 12 months, number of distinct commands created by neuronal activity, and the use of the system for digital device control.

Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients: The Stentrode With Thought-Controlled Digital Switch Study - SWITCH