Spinal Cord Injury (SCI)NCT06965127
Implant for Walking After Incomplete SCI
A study testing NNP-LE in people with Spinal Cord Injury (SCI) and Gait, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury (SCI), Gait
- What is being tested?
- NNP-LE
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2025to Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, 44106
Lisa Lombardo, MPT, 216-791-3800 ext. 64909, lisalombardo2@va.gov
Maura Malenchek, PTA, 216-791-3800 ext. 64989, maura.malenchek@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injury (SCI), Gait
- Being tested
- NNP-LE
- Keywords
- neuroprosthesis, implanted device
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNP-LEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Implantation, controller development and evaluation | Experimental | 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. Receives: Device: NNP-LE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the participant is fully trained to use their implanted system
Secondary outcomes (2)
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.
Measured: Immediately after the participant is fully trained to use their implanted system
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.
Measured: Baseline and Immediately after the participant is fully trained to use their implanted system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start27 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- MetroHealth Medical Center, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Nathan Makowski, Louis Stokes VA Medical Center
- Investigators
- Nathan Makowski, PhD, Principal investigator, MetroHealth System, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965127
- Sponsor's protocol ID
- 1802378
- Other IDs
- CDMRP-SC230198
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified assessment data will be shared via open data commons for spinal cord injury
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Walking and Independence After Incomplete SCI With a Fully Implanted Neuroprosthesis
- ClinicalTrials.gov ID
- NCT06965127
- Acronym / sponsor ID
- 1802378
- Conditions
- Spinal Cord Injury (SCI), Gait
- Keywords
- neuroprosthesis, implanted device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Collaborators
- MetroHealth Medical Center, Congressionally Directed Medical Research Programs
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantation, controller development and evaluation | Experimental | Device: NNP-LEThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNP-LENetworked 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. | Device | Implantation, controller development and evaluation |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified assessment data will be shared via open data commons for spinal cord injury
Related trials for Spinal Cord Injury (SCI)
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NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan Makowski, PhD principal investigator
MetroHealth System, Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NNP-LE in people with Spinal Cord Injury (SCI) and Gait, run by Louis Stokes VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Lombardo, MPT (216-791-3800 ext. 64909, lisa.lombardo2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in maximum walking distance (time frame: Immediately after the participant is fully trained to use their implanted system). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.