Implant for Walking After Incomplete SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLouis Stokes VA Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 18-75
Non-ventilator dependent paralysis resulting from injuries such as: cervical/thoracic spinal cord injuries affecting the trunk and/or lower limbs
Impairment classification of AIS B, C, or D (preservation of sensation and/or some motor function) with weakness in trunk and/or lower extremity muscles
Unable to walk faster than 0.8m/s during a 10m walk test
Disqualifiers
Significant fracture risk or history of spontaneous fractures
History of heterotopic ossification at the hip, knee, or ankle
Non-English speaking
Insufficient upper extremity function to use an assistive device (e.g. walker or cane)
Trial design
Design model
Single group
Treatments tested in this trial
NNP-LE
DeviceNetworked 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.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Implantation, controller development and evaluationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference 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 systemSecondary outcomes
1
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 system2
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 systemSponsors and contacts
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Source ClinicalTrials.gov