Implant for Walking After Incomplete SCI

November 20, 2025 updated by: Nathan Makowski, Louis Stokes VA Medical Center

Enhancing Walking and Independence After Incomplete SCI With a Fully Implanted Neuroprosthesis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Louis Stokes Cleveland Veterans Affairs Medical Center
        • Contact:
        • Principal Investigator:
          • Nathan Makowski, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implantation, controller development and evaluation
This phase includes installing the device and setting the individual up for use of the system and evaluating the effect of the system on walking ability.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in maximum walking distance
Time Frame: Immediately 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.
Immediately after the participant is fully trained to use their implanted system

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in spinal cord injury - functional ambulation inventory (SCI-FAI)
Time Frame: Immediately after the participant is fully trained to use their implanted system
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.
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
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.
Baseline and Immediately after the participant is fully trained to use their implanted system

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louis Stokes VA Medical Center

Collaborators

MetroHealth Medical Center
CDMRP

Investigators

  • Principal Investigator: Nathan Makowski, PhD, MetroHealth System, Ohio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

May 1, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1802378
  • CDMRP-SC230198 (Other Grant/Funding Number: DoD CDMRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified assessment data will be shared via open data commons for spinal cord injury

IPD Sharing Time Frame

data will become available after study completion

IPD Sharing Access Criteria

de-identified data will be available to anyone with access to the ODC-SCI repository

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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