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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Louis Stokes VA Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MetroHealth Medical Center
CDMRP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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