Spinal Cord Injury (SCI) affects ~300,000 people in the US, with 11,000 new cases/year. After SCI, spinal reflexfunction becomes abnormal, contributing to motor impairments and spasticity that affects 65-78% of peoplewith SCI. Thus, restoring the function of spinal reflex pathways is a major therapeutic goal. Current therapiesare only moderately successful; motor function often does not return to pre-injury levels.Research led by Dr. Wolpaw at the National Center for Adaptive Neurotechnologies (NCAN) and Dr. Thompsonat the Medical University of South Carolina (MUSC) has developed a novel noninvasive therapy that targetsbeneficial change to specific spinal reflex pathways. The patient learns, through operant conditioning, to modifythe brain's control over the pathway. This modified control gradually changes the pathway, and triggers favorableplasticity in other pathways as well. In people with SCI, spinal reflex conditioning reduces spasticity, eliminateslimping, and increases walking speed. The benefits persist; and they are apparent to people in their daily lives.Clinical translation of this powerful new therapy is now impractical because the reflex conditioning system iscomplex and requires a highly-trained operator. To realize its therapeutic potential, reflex conditioning needs anintegrated hardware/software system that can be mastered quickly and used effectively by therapists. BioCircuitTechnologies has the essential hardware; NCAN and MUSC have the essential software and clinical expertise.BioCircuit has a strong record in transforming complex technology into turnkey systems. Working together,BioCircuit, NCAN, and MUSC propose to create a reflex conditioning system suitable for widespread clinical use.Phase I - Aim 1 will integrate hardware to record EMG from multiple sites and stimulate the peripheral nervewith software to control recording and stimulation and provide real-time visual feedback to the patient andresults to the therapist. This new system will combine BioCircuit's recording/stimulation platform, NCAN'sautomated algorithms, and MUSC's clinical methods. Through formal clinician usability tests, we will optimizethe system and confirm its robustness and usability. Aim 2 will establish the device compliance and regulatorypathway based on FDA feedback, bring development under design and quality system control, ensure regulatorycompliance, and guide the Phase II clinical study and the pathway to a future FDA 510(k) submission.Phase II - Aim 1 will validate the effectiveness of the new system in people with chronic incomplete SCI. Weexpect that reflex conditioning with the new system will equal or exceed that of the old system. Aim 2 will assessthe impact of the new system on motor function, quality of life, and community participation. We expect that itsbenefits will equal or exceed those of the old system. These studies will identify metrics for a large post-Phase IIstudy. Aim 3 will gather initial data on safety for an FDA 510(k) submission for use in SCI.This project will produce a robust clinically practical reflex conditioning system that enables this noninvasivenew therapy to complement traditional therapies and enhance recovery for people with SCI and other disorders.
Public Health Relevance Statement: Project Narrative
Abnormal spinal reflexes impair walking and other motor functions in many people with incomplete spinal cord
injury (SCI). New therapies are needed. Spinal reflex conditioning is a novel noninvasive therapy that modifies
these spinal reflexes to reduce spasticity, eliminate limping, and increase walking speed. This project will result
in a robust, validated, clinically practical reflex conditioning system that enables this powerful new therapy to
complement traditional therapies and enhance functional recovery for people with SCI and other disorders.
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