47238 Results of the Command Trial: An Early Feasibility Study of the Synchron Endovascular Brain-Computer Interface

INTRODUCTION: Implantable Brain-computer interfaces (BCIs) aim to provide people with paralysis a means to control devices using decoded brain signals. Predominantly, implantable BCIs have required craniotomy to place penetrating or surface electrodes on the brain. Here, we present the results of an early feasibility study (EFS) of the Synchron BCI, a fully implanted system delivered using a minimally invasive endovascular technique. METHODS: The COMMAND EFS, a multi-center, prospective, single-arm, open label clinical trial conducted under an investigational device exemption, evaluated the safety and feasibility of the Synchron BCI in subjects with chronic severe bilateral upper limb paralysis. The primary safety endpoint was device related serious adverse events resulting in death or permanent increased disability. Secondary safety endpoints were device migration and target vessel patency. Efficacy was assessed via use of the BCI for motor intent transmission, digital device control, and patient-reported outcomes. RESULTS: A total of six subjects with preserved motor cortex activity and suitable venous anatomy were implanted with the endovascular BCI. Preliminary safety and efficacy data for all six patients will be presented in addition to video demonstrations of the BCI used for digital device control. CONCLUSIONS: Endovascular access to brain regions for the placement of BCI sensors is an alternative to procedures requiring a craniotomy via open-brain surgery. In addition to the favorable safety profile of endovascular procedures, the prevalence of angiography suites and neurointerventionalists capable of performing these procedures could promote wider and more rapid translation of BCI for people with paralysis. Results from the COMMAND EFS trial demonstrate early indication of safety and effectiveness of Synchron’s endovascular BCI for patients with severe bilateral upper limb paralysis.