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Spinal Cord InjuryPhase 2NCT04241250

Neuromodulation Techniques After SCI

A Phase 2 study testing EAW+SCES (exoskelton and spinal cord epidural stimulation) and EAW+TS (exoskelton and transspinal stimulation) in people with Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Spinal cord injury (SCI) leads to several health-related consequences often linked to reduced levels of physical activity. Direct stimulation of the spinal cord, either through implanted devices or surface stimulation, has been combined with intense physical therapy assisted treadmill walking to facilitate independent… Read more about this study

Who is it for?
Ages 18 to 70 years, men only
Conditions the study is for
Spinal Cord Injury
What is being tested?
EAW+SCES (exoskelton and spinal cord epidural stimulation) and EAW+TS (exoskelton and transspinal stimulation)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
1 Jun 2020to 31 Dec 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All participants will be between 18-70 years old, male, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam
  • All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included

Who cannot join

  • Participants with any of the following pre-existing medical conditions will be excluded from the current trial:
  • Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia
  • Unhealed fracture in either lower or upper extremities
  • Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees
  • Untreated or uncontrolled hypertension defined as high resting blood pressure greater than 140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture
  • Other medical conditions including cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater, or symptomatic urinary tract infection
Show all 18Show fewer
  • Unable to fit in the device for any reason
  • Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons
  • Implanted pacemakers and/or implanted defibrillator devices
  • DXA T-Score less than -2.5. Scans done will include total body, dual hips and knees. Total hip BMD T-scores < -3.5 and knee BMD scores of less than 0.6 g/cm2
  • Functional upper and lower extremity ROM, strength, spasticity and skin integrity will also have assessed prior to enrollment in the program.
  • The Modified Ashworth Scale will be used to ensure safety of the participants prior to engagement in the rehabilitation program
  • Participants with severe spasticity or limited ROM will be excluded from the trial
  • This is based on the Ekso manufacturer's recommendations
  • Untreatable severe spasticity judged to be contraindicated by the site Physician
  • Pressure ulcer of the trunk, pelvic area, or lower extremities of grade 3 or more
  • Psychopathology documentation in the medical record or history that may conflict with study objectives
  • Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study and/or increases the risk of infection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249-0001

Other trials in United States

About this study

Official title: Transspinal Versus Epidural Stimulation for Exoskeletal Assisted Walking After Spinal Cord Injury

Spinal cord injury (SCI) leads to several health-related consequences often linked to reduced levels of physical activity. Direct stimulation of the spinal cord, either through implanted devices or surface stimulation, has been combined with intense physical therapy assisted treadmill walking to facilitate independent standing and stepping. These current methods require 3-4 highly skilled therapists and may not be feasible in all rehabilitation settings, especially when considering the growing number of SCI patients each year. Therefore, the use of robotic exoskeleton suits combined with direct stimulation of the spinal cord (requiring 1-2 therapists) may offer an alternative rehabilitation approach to overcome their limited abilities to stand and walk. Such improvements may also help to reverse or eliminate other health-related consequences associated with SCI. The pilot work will provide the preliminary evidence required to design future clinical trials for Veterans and civilians with SCI to restore overground mobility.

Read the detailed description

Restoring locomotion following spinal cord injury (SCI) has been the focus of years of research aimed at ameliorating several of health-related comorbidities. Spinal cord epidural stimulation (SCES) exhibits the rehabilitation potential of restoring locomotion in individuals with SCI when combined with intensive locomotion training. Despite this potential, such protocols are likely impractical when applied across large clinical SCI populations due to high monetary costs. Similar to SCES, transspinal stimulation (TS) has also exhibited neuromodulatory benefits by externally stimulating lumbro-sacral neural circuity to generate step-like activities in persons with complete SCI; however, these techniques also require intense gait training. Recently robotic exoskeletons have been used as a promising tool to circumvent limitations associated with labor-intensive locomotor training, and have been safely used as an effective approach in improving levels of physical activity in persons with complete SCI.

Recent work has demonstrated the benefits of combining EAW and neuromodulatory techniques. Following 12-weeks of EAW+SCES training, improvements in locomotion led researchers to decrease the amount of EAW swing assistance to 35% in a person with a C7 complete SCI. This was accompanied by 573 unassisted steps, which represents 50% of the total number of steps taken during that session. Electromyographic (EMG) activity also increased during both stance and swing phases, reflecting the individual's ability to rhythmically fire paralyzed muscles during EAW+SCES. Additionally, cardio-metabolic loads were increased during exoskeletal stepping when combined with SCES as compared to stepping without SCES. The participant also showed a modest decrease in his total and regional absolute fat mass. These preliminary findings suggest that neuromodulation using SCES with exoskeletal ambulation may provide a feasible rehabilitation approach for persons with SCI. The goal of the current study is to examine and compare the effects of EAW combined with SCES or TS in persons with motor complete SCI. The data generated from this application will also enable larger clinal trials to explore ways to optimize exoskeletal assisted gait training through the use of different neuromodulation modalities with SCI.

Following a repeated-measure design, 10 participants with chronic, motor complete (AIS A and B) SCI (age:18-60 years) will be randomly assigned to participate in either 6-months of EAW+SCES (n=5) or EAW+TS (n=5) training. The entire duration of the trial will be approximately 1 year for each participant. Initially, participants will undergo 3-months of EAW training (3 sessions/week), which will be followed by randomization into either a EAW+SCES group or EAW+TS group for an additional 6-months of training (both groups: 3 sessions/week) and a 3-month follow-up period for both groups. Measurements at baseline (BL: prior to EAW) and 4 post-intervention timepoints will occur every 3-months (P1: following 3-months of EAW; P2: following 3-months of EAW+TS or EAW+SCES; P3: after completing 6-months of EAW+TS or EAW+SCES; P4: 3-months after termination of EAW+TS or EAW+SCES).

This pilot work will have 3 specific aims: Aim 1. The investigators will determine and compare improvements to locomotor control following 6 months of EAW+TS and EAW+SCES as measured by 10-meter walking speed, the number of unassisted EAW steps, and EMG activity.

Aim 2. The investigators will determine and compare improvements to cardio-metabolic risk factors following 6 months of EAW+TS and EAW+SCES as measured by total and regional body composition, oxygen uptake, and fasting lipid profile.

Aim 3. The investigators will determine and compare improvements in bladder health following 6 months of EAW+TS and EAW+SCES as measured by bladder filling and emptying

Being tested
EAW+SCES (exoskelton and spinal cord epidural stimulation), EAW+TS (exoskelton and transspinal stimulation)
Keywords
Robotic Exoskeleton, Epidural Stimulation, Transspinal stimulation, Spinal cord injury, Rehabilitation
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.

  • EAW+SCES (exoskelton and spinal cord epidural stimulation)Device

    Three months of exoskeleton training followed by 6 months of epidural stimulation.

  • EAW+TS (exoskelton and transspinal stimulation)Device

    Three months of exoskeleton training followed by 6 months of transspinal stimulation.

Study groups in NCT04241250
Study groupRoleWhat they receive
EAW+SCESExperimentalThree months of exoskeleton training followed by 6 months of epidural stimulation.
Receives: Device: EAW+SCES (exoskelton and spinal cord epidural stimulation)
EAW+TSExperimentalThree months of exoskeleton training followed by 6 months of transspinal stimulation.
Receives: Device: EAW+TS (exoskelton and transspinal stimulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10-meter Walking Speed (m/Sec)

    After fitted in the robotic exoskeleton, the participant will be asked to walk for 10-meter distance and the time and speed will be determined. Measurements were conducted over the course of 9 months.

    Measured: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)

  2. Muscles Electromyography (EMG) Activity (Micro-volts)

    Representative EMG activities of the right VL muscle during the entire gait cycle of the 10 meter walking test at baseline (BL) and post-intervention (PI) measurements over the course of 9 months.

    In the EAW+SECES, participants had undergone EMG measurements during exoskeletal-10-meter walking test at baseline (BL) and after 6 months (P3) following implantation of spinal cord epidural stimulation (SCES).

    The EMG tests were performed at 100% exoskeletal assisted walking (EAW) or reduced EAW (RED-EAW) at Baseline and P3. At P3, the EMG tests were performed three times; one at 100%-EAW, RED-EAW without SCES and RED-EAW with SCES.

    Measured: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)

Secondary outcomes (4)

  1. Percentage Fat Mass

    Body composition will be captured using dual energy x-ray absorptiometry (DXA) to measure fat mass (FM; %) every 3 months during the course of 9-month trial.

    Measured: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)

  2. Oxygen Uptake (L/Min)

    Oxygen uptake during resting, standing and walking will be measured during 6 minutes walking test every 3 months during the course of the trial.

    Measured: [Time Frame: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)]

  3. Fasting Lipid Profile (mg/dl)

    After overnight fast, blood will be drawn to measure your circulating triglycerides, low and high density lipoproteins and cholesterol.

    Measured: [Time Frame: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)]

  4. Fat-Free Mass

    Body composition will be captured using dual energy x-ray absorptiometry (DXA) to measure fat mass (FFM; kg) every 3 months during the course of 9-month trial.

    Measured: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2020
  2. Study start1 Jun 2020
  3. Primary completion31 Jul 2024
  4. Study completion31 Dec 2024

Resources

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 2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Exoskeletal assisted walking and spinal cord epidural stimulation (EAW+SCES) Exoskeletal assisted walking and Transspinal stimulation (EAW+TS)
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04241250
Sponsor's protocol ID
B3456-P
Status last verified
Apr 2026
First submitted
10 Jan 2020
Last updated
28 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Hachmann JT, Yousak A, Wallner JJ, Gad PN, Edgerton VR, Gorgey AS. Epidural spinal cord stimulation as an intervention for motor recovery after motor complete spinal cord injury. J Neurophysiol. 2021 Dec 1;126(6):1843-1859. doi: 10.1152/jn.00020.2021. Epub 2021 Oct 20.

    PubMed 34669485

  • Gorgey AS, Trainer R, Sutor TW, Goldsmith JA, Alazzam A, Goetz LL, Lester D, Lavis TD. A case study of percutaneous epidural stimulation to enable motor control in two men after spinal cord injury. Nat Commun. 2023 Apr 12;14(1):2064. doi: 10.1038/s41467-023-37845-7.

    PubMed 37045845

  • Alazzam AM, Ballance WB, Smith AC, Rejc E, Weber KA 2nd, Trainer R, Gorgey AS. Peak Slope Ratio of the Recruitment Curves Compared to Muscle Evoked Potentials to Optimize Standing Configurations with Percutaneous Epidural Stimulation after Spinal Cord Injury. J Clin Med. 2024 Feb 27;13(5):1344. doi: 10.3390/jcm13051344.

    PubMed 38592158

  • Gorgey AS, Goldsmith J, Alazzam A, Trainer R. Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. Front Neurosci. 2023 Feb 16;17:1112853. doi: 10.3389/fnins.2023.1112853. eCollection 2023.

    PubMed 36875669

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EAW+SCES (exoskelton and spinal cord epidural stimulation) and EAW+TS (exoskelton and transspinal stimulation) in people with Spinal Cord Injury, run by VA Office of Research and Development 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 2 inclusion and 18 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: finished, as of the sponsor's last update on 28 Apr 2026. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10-meter Walking Speed (m/Sec) (time frame: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04241250, which also lists 4 linked publications.

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 28 Apr 2026.

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