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Implant for Walking After Incomplete Spinal Cord Injury

This study is testing a device called NNP-LE (Networked NeuroProsthesis - Lower Extremity Configuration) to see if it can help people with incomplete spinal cord injury (SCI) walk better. The NNP-LE is an implanted stimulator that measures signals from your body and delivers electrical stimulation to your muscles to help with movement. You might be able to join if you are between 18 and 75 years old, have paralysis from a cervical or thoracic SCI that affects your trunk or legs, and have some sensation or motor function (AIS B, C, or D). The main goal is to see how much your maximum walking distance improves after you've been fully trained to use the implanted system. The study is currently unclear on its recruitment status.

Study design
This is an interventional device study with a planned enrollment of 5 participants. It involves two phases: screening, and then implantation, controller development, and evaluation.
What's involved
You would undergo pre-surgical gait training, surgery to implant the device, and then training to use the device to assist walking. Evaluations are done before surgery, after training, and at later follow-up sessions over a couple of years.
Compensation
Not stated in the trial record.
Follow-up
Your walking will be evaluated immediately after you are fully trained to use the implanted system, and at later follow-up sessions over a couple of years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06965127

Implant for Walking After Incomplete SCI

Recruiting
NAAges 18–75InterventionalTreatment
Louis Stokes VA Medical Center
~5 participants
Updated 2025-11-26 on ClinicalTrials.gov
What's tested:NNP-LE

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in maximum walking distance
Measured over Immediately after the participant is fully trained to use their implanted system

Conditions

Spinal Cord Injury (SCI)
Gait

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Nathan Makowski, PhD · PRINCIPAL_INVESTIGATOR · MetroHealth System, Ohio

Who to contact

Lisa Lombardo, MPT
[email protected]
216-791-3800 · ext. 64909
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Difference in maximum walking distanceImmediately after the participant is fully trained to use their implanted system

    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.