Stage I Translation Award Winner: John Simeral


Summary:

Preclinical testing of a high-performance wireless neural interface for individuals with SCI

Intracortical neural interfaces promise natural, effective, adept control of enabling assistive technologies for individuals with paralysis arising from spinal cord injury as well as other neurological conditions including stroke and ALS. Individuals with tetraplegia in the pilot clinical trial of the BrainGate (IDE*) neural interface system have demonstrated intracortical neural control of computer cursors (communication software, Google Chat, etc.) and assistive devices including the DEKA prosthetic arm/hand system, assistive robots and a simulated FES-activated arm1–5. 

In addition to Brown University and Massachusetts General Hospital, the BrainGate collaboration now includes clinical trial sites at Stanford University, the Providence VA Medical Center, and the Cleveland VA Functional Electrical Stimulation (FES) Center where trial participants with upper limb paralysis will use their BrainGate-enabled neural commands to achieve functional tasks through coordinated FES control of upper extremity muscles. While ongoing research is extending the precision, reliability, and automation of this neural prosthetic system6–10, to enable independent use of this technology at home or in a wheelchair without supervision from trained technicians will require converting the present rack of computing hardware to a compact mobile system and replacing the current Blackrock Microsystems (Salt Lake City, UT) connection cable with a wireless transmitter. 

Toward the mobile system, our VA-funded research is developing a battery-powered embedded platform to perform real-time neural decoding on a wearable device11. Toward the wireless requirement, our team has for years been developing and testing an unprecedented high-throughput wireless device12–16 suitable to replace the present recording cable and to deliver neural signals to existing neural decoding hardware and our mobile processing microsystem. Our external wireless transmitter design was recently licensed to Blackrock for manufacturing improvements and commercialization for the animal research market; however, Blackrock is not pursuing approval for human use due in part to the comparatively small assistive technology market for individuals with spinal cord injury. FDA approved use of a wireless transmitter is a critical step toward practical, independent, long-term use of an intracortical neural interface, but the requisite preclinical testing is challenging to fund as either basic research or innovative engineering. 

This proposal will complete engineering tests in support of an IDE supplement to the FDA for use of this wireless device in humans. Test results will be provided to Dr. Hochberg at Massachusetts General Hospital whose legal and clinical team will prepare an IDE supplement referencing the safety report generated by this proposal. This represents a critical, difficult-to-fund step toward truly independent home use of restorative/assistive technologies that will promote independence for individuals with paralysis.  

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