Spinal Reflex Conditioning System for Enhancing Motor Function Recovery After Incomplete Spinal Cord Injury

Project Summary Spinal Cord Injury (SCI) affects ~300,000 people in the US, with 11,000 new cases/year. After SCI, spinal reflex function becomes abnormal, contributing to motor impairments and spasticity that affects 65-78% of people with SCI. Thus, restoring the function of spinal reflex pathways is a major therapeutic goal. Current therapies are 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. Thompson at the Medical University of South Carolina (MUSC) has developed a novel noninvasive therapy that targets beneficial change to specific spinal reflex pathways. The patient learns, through operant conditioning, to modify the brain’s control over the pathway. This modified control gradually changes the pathway, and triggers favorable plasticity in other pathways as well. In people with SCI, spinal reflex conditioning reduces spasticity, eliminates limping, 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 is complex and requires a highly-trained operator. To realize its therapeutic potential, reflex conditioning needs an integrated hardware/software system that can be mastered quickly and used effectively by therapists. BioCircuit Technologies 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 nerve with software to control recording and stimulation and provide real-time visual feedback to the patient and results to the therapist. This new system will combine BioCircuit’s recording/stimulation platform, NCAN’s automated algorithms, and MUSC’s clinical methods. Through formal clinician usability tests, we will optimize the system and confirm its robustness and usability. Aim 2 will establish the device compliance and regulatory pathway based on FDA feedback, bring development under design and quality system control, ensure regulatory compliance, 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. We expect that reflex conditioning with the new system will equal or exceed that of the old system. Aim 2 will assess the impact of the new system on motor function, quality of life, and community participation. We expect that its benefits will equal or exceed those of the old system. These studies will identify metrics for a large post-Phase II study. 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 noninvasive new therapy to complement traditional therapies and enhance recovery for people with SCI and other disorders.