Endovascular Brain-Computer Interface to Restore Motor Control for the Command of Digital Devices in Patients with Severe Quadriparesis
Shahram Majidi1, Noam Harel4, Miguel Escalon2, Abbey Sawyer5, Marta Lapinska5, Aidan Rogers5, Raul Nogueira6, Douglas Weber7, David Putrino3
1Neurosurgery, Neurology, 2Rehabilitation and Physical Medicine, Icahn School of Medicine at Mount Sinai, 3Icahn School of Medicine at Mount Sinai, 4Neurology, James J. Peters VAMC, Icahn School of Medicine at Mount Sinai, 5Rehabilitation and Physical Medicine, Mount Sinai, 6Neurology, UPMC, 7Department of Mechanical Engineering and Neuroscience Institute, CMU
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 (StentrodeTM), 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.