Endovascular Brain-Computer Interface to Restore Motor Control for the Command of Digital Devices in Patients with Severe Quadriparesis (S38.001)

Objective:

To present the first US implant of endovascular Brain-Computer Interface (BCI) to Restore Motor Control of Digital Devices in a patient with ALS.

Background:

BCI has the potential to restore the transmission of neural signal from the cerebral cortex to control digital devices and improve functional independence in patients with severe paralysis.

Design/Methods:

COMMAND is an FDA-approved, NIH-funded single arm, open-label, prospective early feasibility study designed to enroll 6 patients with severe quadriparesis to receive an endovascular implantable motor neuroprosthesis (Stentrode, Synchron Inc, Brooklyn, NY). The primary outcome measures include treatment related serious adverse events within 12-month after device implantation. Secondary outcome measures include restoration of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices. The study device comprises of three parts: 1) Endovascular electrode array and lead (Stentrode™), implanted percutaneously via the jugular vein in the superior sagittal sinus adjacent to the motor cortex using endovascular approach; 2) Implantable Receiver Transmitter Unit (IRTU) implanted in the pectoral region; and 3) Controller, including an External Receiver Transmitter Unit (ERTU), Signal Control Unit (SCU) and Software Application.

Results:

A 67 year-old patient with complete quadriplegia from amyotrophic lateral sclerosis (ALS) enrolled into the study. Using a right internal jugular vein access, the investigational endovascular Stentrode BCI was implanted in the superior sagittal sinus adjacent to primary motor cortex. The patient tolerated the procedure very well, without any procedure related complications. He has been getting machine-learning-assisted training to use wirelessly transmitted electrocorticography signals associated with attempted movements to control multiple mouse-click actions. His 3-month follow up CTV revealed patency of cerebral venous system.

Conclusions:

We describe the first US in-human experience of a minimally invasive, fully implanted, wireless motor neuroprosthesis using an endovascular stent-electrode array to transmit electrocorticography signals from the motor cortex for multiple command control of digital devices. Disclosure: Dr. Majidi has nothing to disclose. Dr. Harel has received personal compensation for serving as an employee of James J. Peters VA Medical Center. Dr. Harel has received personal compensation for serving as an employee of Icahn School of Medicine at Mount Sinai. Dr. Harel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for RubiconMD. Dr. Harel has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Dalton & Finegold, LLP. The institution of Dr. Harel has received research support from NIH. The institution of Dr. Harel has received research support from Craig H. Neilsen Foundation. The institution of Dr. Harel has received research support from New York State Department of Health. The institution of Dr. Harel has received research support from VA Rehabilitation Research and Development. Dr. Harel has a non-compensated relationship as a Neurology Editorial Board Member with AAN that is relevant to AAN interests or activities. Dr. Harel has a non-compensated relationship as a Member, Board of Directors with American Society of Neurorehabilitation that is relevant to AAN interests or activities. Dr. Harel has a non-compensated relationship as a Chair, AAN Spine Section with AAN that is relevant to AAN interests or activities. The institution of Dr. Escalon has received research support from NIH. Dr. Sawyer has nothing to disclose. Miss Lapinska has nothing to disclose. Aidan Rogers has nothing to disclose. Dr. Nogueira has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for for advisory roles with Anaconda, Biogen, Cerenovus, Genentech, Hybernia, Imperative Care, Medtronic, Phenox, Philips, Prolong Pharmaceuticals, Stryker Neurovascular, Shanghai Wallaby, and Synchron (consulting fees) as well as for advisory roles with Astrocyte, Brainomix, Cerebrotech, Ceretrieve, Corindus Vascular Robotics, Vesalio, Viz-AI, RapidPulse and Perfuze ( stock options). Dr. Nogueira has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Law Firms. Dr. Nogueira has received stock or an ownership interest from Viz-AI, Perfuze, Cerebrotech, Reist/Q’Apel Medical, Truvic, and Viseon. The institution of Dr. Nogueira has received research support from Cerenovus. Prof. Weber has received personal compensation for serving as an employee of Carnegie Mellon University. Prof. Weber has received personal compensation for serving as an employee of Iota Biosciences. Prof. Weber has stock in Microsoft. Prof. Weber has stock in Meta Platforms. Prof. Weber has stock in Apple. The institution of Prof. Weber has received research support from NIH. The institution of Prof. Weber has received research support from DARPA. The institution of Prof. Weber has received research support from Lockheed Martin. Prof. Weber has received intellectual property interests from a discovery or technology relating to health care. An immediate family member of Dr. Putrino has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Psilobrain, LLC. Dr. Putrino has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Thorne Healthtech. Dr. Putrino has received stock or an ownership interest from Precision Recovery, Inc. The institution of Dr. Putrino has received research support from National Institutes of Health. The institution of Dr. Putrino has received research support from New York State Spinal Cord Injury Research Board. The institution of Dr. Putrino has received research support from Gondola, Inc. The institution of Dr. Putrino has received research support from SimpleTherapy, Inc. The institution of Dr. Putrino has received research support from CelloScope. Dr. Putrino has received intellectual property interests from a discovery or technology relating to health care. Dr. Putrino has received intellectual property interests from a discovery or technology relating to health care. Dr. Putrino has received intellectual property interests from a discovery or technology relating to health care. Dr. Putrino has received intellectual property interests from a discovery or technology relating to health care. Dr. Putrino has received publishing royalties from a publication relating to health care.