Implant for Walking After Incomplete SCI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NNP-LE.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury (SCI), Gait. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Enhancing Walking and Independence After Incomplete SCI With a Fully Implanted Neuroprosthesis
Overview
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.
Detailed description
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.
Interventions
- Device NNP-LE
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.
Primary outcome measures
- Difference in maximum walking distance [Time frame: Immediately after the participant is fully trained to use their implanted system]
Secondary outcome measures (2)
- Difference in spinal cord injury - functional ambulation inventory (SCI-FAI) [Time frame: Immediately after the participant is fully trained to use their implanted system]
- Difference in Home and community mobility [Time frame: Baseline and Immediately after the participant is fully trained to use their implanted system]
Eligibility criteria
Inclusion criteria
- 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
- Gait deviation such as reduced peak hip, knee, and/or ankle range of motion during stance or swing phases due to motor impairment
- Time post injury greater than six months
- Innervated and excitable lower extremity and trunk musculature
- Adequate social support and stability
- Willingness to comply with follow-up procedures
- Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
- Neurologically stable as determined by a physician
Exclusion criteria
- 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)
- Females who are pregnant
- Current pressure injury that would be exacerbated by study activities
- Uncontrolled spasticity that would interfere with study activities
- Significant range of motion limitations that would compromise study activities
- History of vestibular dysfunction, balance problems, or spontaneous falls
- Disorder or condition that require MRI monitoring
- Acute and/or untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture
- Acute and/or chronic medical problems left untreated or not controlled that would increase risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise
- Uncontrolled diabetes or hypertension
- Presence of a demand pacemaker, cardiac defibrillator, or neuroprosthesis system with components in the legs
- Any other medical or psychological condition that would be a contraindication
Implant eligibility criteria
- In addition to all of the above, the participant must be able to fully support their body weight in standing with an assistive device prior to implantation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Louis Stokes Cleveland Veterans Affairs Medical Center — Cleveland
Identifiers
NCT: NCT06965127 · 1802378 · CDMRP-SC230198