More than 1.2 million people in the United States have a spinal cord injury (SCI), and each year there are 10,000 new cases. In the last few years, we have shown that neuromodulation using epidural stimulation of the lumbosacral spinal cord can activate latent neural circuits and restore voluntary movement, standing and stepping in individuals with chronic SCI. One participant in this study also reported gains in bladder function following training with spinal cord epidural stimulation. However, there are persistent gaps that need to be filled in order to advance the field of neuromodulation forward. Technological advances to upgrade the stimulator?s programming and wireless communication platforms are critically needed in order to integrate multiple training paradigms across multiple systems (i.e. motor and autonomic), as well as take advantage of wireless monitoring technology that could improve the patient experience. For this study, first we will acquire data necessary for the implementation of learning algorithms and closed-loop systems with the implanted neurostimulator. Second, 8 additional individuals will be randomized into training interventions for locomotion and bladder. The purpose of this phase is to implement the closed-loop controls and learning algorithms developed with data from phase 1. This two phase design will allow us to acquire necessary data for the development of technical tools with a group of 8 individuals, and test the closed-loop controls with a second group of individuals that have not received prior to training. This trial will upgrade technology for epidural stimulation and make it specific for use by individuals with spinal cord injury.

Public Health Relevance

We propose a small scale pilot clinical trial to evaluate technology specific improvements for the use of spinal cord epidural stimulation to function in individuals with spinal cord injury. We will develop technology that will interact with currently available stimulators, to facilitate the implementation and integration of training programs for the recovery of locomotion and bladder function in individuals with acute spinal cord injury and promote safe long-term use of the technology in the home and community. This study will start addressing some technology gaps by developing a flexible communication platform specific for spinal cord injury.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Exploratory/Developmental Cooperative Agreement Phase II (UH3)
Project #
1UH3NS116238-01
Application #
9962062
Study Section
Special Emphasis Panel (ZNS1)
Program Officer
Gross, Brooks Andrew
Project Start
2020-09-15
Project End
2025-06-30
Budget Start
2020-09-15
Budget End
2021-06-30
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Louisville
Department
Neurosurgery
Type
Schools of Medicine
DUNS #
057588857
City
Louisville
State
KY
Country
United States
Zip Code
40292