# Spinal reflex conditioning system for enhancing motor function recovery after incomplete spinal cord injury

> **NIH NIH U44** · BIOCIRCUIT TECHNOLOGIES, INC. · 2020 · $856,772

## Abstract

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 gath...

## Key facts

- **NIH application ID:** 10045442
- **Project number:** 1U44NS114420-01A1
- **Recipient organization:** BIOCIRCUIT TECHNOLOGIES, INC.
- **Principal Investigator:** Isaac Perry Clements
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $856,772
- **Award type:** 1
- **Project period:** 2020-09-30 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10045442

## Citation

> US National Institutes of Health, RePORTER application 10045442, Spinal reflex conditioning system for enhancing motor function recovery after incomplete spinal cord injury (1U44NS114420-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10045442. Licensed CC0.

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