A User-Friendly, Noninvasive Neuro-Orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors with Tetraplegia
Abstract
Objectives and Rationale for Proposed Research: In the United States alone, more than 100,000 individuals currently live without the ability to use their hands due to cervical spinal cord injury (SCI). More than 10,000 additional SCI cases resulting in tetraplegia occur each year, with an estimated 225 cases occurring in U.S. military members. The inability to perform everyday tasks that require hand function, such as eating, bathing, and grooming, results in loss of independence and reliance on caregivers to complete activities of daily living. Unfortunately, current interventions on the market are lacking the ability to restore skilled hand function to affected individuals. This study will evaluate our user-friendly, non-invasive NeuroLife system as both an orthosis for returning grasp function during use, and as a rehabilitation tool for improving hand function after use. The NeuroLife device is a high-density sleeve electrode array worn on the forearm that can simultaneously record residual, sub-movement threshold muscle activity (called electromyography, or EMG) from the paralyzed muscles and provide functional electrical stimulation (FES) to stimulate muscle contraction, evoking the desired movement, thus enabling user-controlled use of an individual’s paralyzed hand. When the user attempts a hand movement, the electrical activity of the muscles is sensed by the sleeve, despite the lack of mobility, and then the intended movement is decoded using machine learning algorithms. The forearm muscles are then electrically stimulated by the FES system to start and stop the desired movement. We have demonstrated the proof-of-concept for this technology, where a study participant with chronic C5/C6 tetraplegia (paralysis from the chest down) was able to use the first generation of the NeuroLife system to control his hand movement using naturalistic motor intention. Additionally, we have recently demonstrated the ability to record EMG and decode multiple motor intention using the NeuroLife sleeve in a participant with motor-complete C5/C6 level SCI, and are encouraged by growing evidence and our own data that suggests intention driven FES therapy can return some muscle function in individuals after SCI. The current NeuroLife system is ready for tests of efficacy in larger patient populations, both as a neuro-orthotic and as a rehabilitation tool, and would benefit from feedback from individuals with SCI, clinicians, and care-givers to further refine the system. In this study, we will test the NeuroLife system in a dual purpose study with 12 participants with chronic SCI. We will evaluate performance improvements with the system active and while it is inactive, relying on the therapeutic benefit of training with the system to perform movements on their own. If successful, we will be well positioned to transition this technology for a follow-on clinical study in a larger population, which will be an important step toward making it available to people who need it. Applicability and Impact of Research: The results of the proposed study will be applicable to individuals with C4-C6 tetraplegia due to an SCI, specifically those who can move their upper arm but are unable to use their wrist and hand. For these individuals, our NeuroLife device will restore functionality of their paralyzed hand, enabling them to perform self-care tasks and increasing their functional independence. Similarly, training with the system will allow individuals improvements to perform movements on their own. Users will be able to select multiple hand movements simply by attempting them. At study completion, we will have tested the NeuroLife system that not only provides hand grasp for those with paralysis, but has been designed to meet user priorities. These data are expected to advance this device toward commercialization, promoting availability as an assistive device and yielding knowledge that is transferrable to other technologies and disease s
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2211083
Entities
People
- Lauren Wengerd
Organizations
- Ohio State University
- United States Army