This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes implanting the device and setting the individual up for system use, creating controllers for walking, and evaluating the effect of the device over a couple years.
The purpose of this study is to evaluate the effects of neural stimulation for improving walking after incomplete spinal cord injury. Participants will conduct pre-surgical gait training and then undergo surgery to implant a stimulator and electrodes to sense from and activate muscles used during walking. The device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. The system coordinates assistance based on implanted sensors. After receiving the implanted device, participants undergo training to use the device to assist walking. Evaluations are completed prior to surgery as well after training and at later follow up sessions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Networked NeuroProsthesis - Lower Extremity Configuration (NNP-LE) measuring physiologic command signals and delivering neural stimulation to intramuscular and nerve cuff electrodes for trunk and leg muscle assistance.
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, United States
RECRUITINGDifference in maximum walking distance
The maximum walking distance is a measure of how far the participant can walk within a single bout over an unconstrained period of time. The measure is used to assess whether endurance and walking capacity improve. The difference between walking with and without the system turned on determines if the system improves walking capacity. Users serve as their own concurrent controls.
Time frame: Immediately after the participant is fully trained to use their implanted system
Difference in spinal cord injury - functional ambulation inventory (SCI-FAI)
The SCI-FAI is an observational gait assessment that assesses three areas of walking: gait parameters, assistive device use, and walking mobility. The difference between walking with and without the system turned on determines if the system improves walking ability. Users serve as their own concurrent controls with and without device assistance.
Time frame: Immediately after the participant is fully trained to use their implanted system
Difference in Home and community mobility
A body worn step counter measures the number of steps taken daily over the course of about a month prior to implantation and then after implantation and system use. The difference between walking before and after having the system identifies if people walk more once they have the system. Users serve as their own longitudinal controls.
Time frame: Baseline and Immediately after the participant is fully trained to use their implanted system
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