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Spinal Cord InjuriesPhase 2/3REST-SCINCT04782947

Epidural Stimulation and Resistance Training After SCI

A Phase 2/3 study testing Exoskeletal assisted walking, Epidural Stimulation and Resistance Training in people with Spinal Cord Injuries, run by United States Department of Defense at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Exoskeletal assisted walking, Epidural Stimulation and Resistance Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
3 Feb 2021to 31 May 2026
Phase
Phase 2/3
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • All participants will be between 18-60 years old, male or female, 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.
  • Participants' knee extensors must respond to standard surface NMES procedures (frequency: 30 Hz; pulse duration:450 μs and amplitude of the current:200 mA) to ensure intact neural circuitry below the level of SCI.
  • 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

  • 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;
  • Unable to fit in the device for any reason;
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  • 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 68-71;
  • 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 recommendations72;
  • 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. Contact the study team or a site near you to ask about taking part.

Ashraf S Gorgey, PhD contact

804675500 ext. 3386

ashraf.gorgey@va.gov

Robert Trainer, MD contact

8046755110

robert.trainer@va.gov

United States1 site, 1 recruiting

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

    Ashraf S Gorgey, MPT,PhD, FACSM, 804-675-5000 ext. 3386, ashraf.gorgey@va.gov

    Lance Goetz, MD, 804-675-5000 ext. 2475, lance.Goetz@va.gov

    Recruiting

Other trials in United States

About this study

Official title: Epidural Stimulation and Resistance Training for Overground Locomotion After Spinal Cord Injury

Spinal cord injury (SCI) is a devastating health problem for tens of thousands of military personnel, Veterans and civilians annually. Many persons with SCI must use a wheelchair for their entire life. A new scientific breakthrough called "lumbosacral epidural stimulation" or "ES" can help people with SCI to stand, step and even walk again. At present, for ES to work, people must train with a specialized treadmill that requires several other qualified personnel to train them, which makes it hard for many people with SCI to benefit from this technology. On the other hand, there are wearable "robot suits" that can be used with ES, which would make it easier to use. Our research team has already used this "ES Robot Suit" for 3 months in one person with tetraplegia and showed remarkable improvements in motor control. Furthermore, the investigators are aiming to enhance overground motor recovery by adding 6 months of resistance training (RT). The addition of RT will likely to enhance muscle quality as indicated by increasing lean mass, peak torque and increase sensory flux to the central nervous system. Other additional benefits may include improvement in cardiovascular profile and bladder functions. The specific objectives of the current proposal are to compare the impact of EAW+ES following improving lower extremity muscle quality compared to those who will only undergo EAW+ ES without conducting RT on motor recovery, cardio-metabolic health and bladder control in persons with complete SCI. At the conclusion of the current proposal, the work will be readily available for translation into clinical setting to serve Veterans and Civilian survivors with SCI.

Read the detailed description

Spinal cord epidural stimulation (ES) is a neuromodulation modality that can facilitate standing, stepping and walking with and without assistive devices in individuals with SCI, however; ES must be accompanied with locomotor training that at present requires a labor-intensive commitment from multiple well-trained personnel using specialized treadmill equipment. Exoskeletal assisted walking (EAW) on the other hand can be safely and efficiently used for ambulation after SCI in combination with ES without the use of other specialized equipment and multiple personnel. The investigators demonstrated that 12-weeks of EAW+ ES resulted in volitional stepping, with improved temporal and rhythmic electromyography (EMG) patterns and speed and with a reduction in EAW assistance to 35%. Unfortunately, EAW+ES does not appear to effectively restore lean mass below the level of injury, which impacts proprioceptive feedback to the spinal locomotor centers. Thus, in addition the investigators have demonstrated that 16-weeks of electrically-evoked resistance training (RT) resulted in robust muscle hypertrophy of the paralyzed knee and hip extensor muscle groups. Therefore, this proposal leverages these research programs by addressing two major gaps; 1) the use of combination EAW+ES as an activity-dependent plasticity tool for restoration of over ground locomotion and 2) enhancement of muscle quality using RT to provide afferent leverage for neuromodulation techniques.

Specific Aims:

  1. To determine the impact of 12 months of EAW+ES+RT on 10-meter over ground walking-speed, number of EAW unassisted steps and EMG patterning compared to 12-months of EAW+ delayed-ES +no-RT (control group).
  2. To determine the impact of 12-months of EAW+ES+RT on blood pressure, total and regional body composition, oxygen uptake as well as anabolic and inflammatory biomarkers compared to the control group.
  3. To determine the impact of 12-months of EAW+ES+RT on parameters of bladder filling and emptying as measured by urodynamic studies compared to the control group.
Being tested
Exoskeletal assisted walking, Epidural Stimulation, Resistance Training, delayed-ES, no-Resistance training
Keywords
neuromodulation, epidural simulation, exoskeletal assisted walking, resistance training, 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.

  • Exoskeletal assisted walkingDevice

    Also called EAW

    Exoskeletal assisted walking includes the use of robotic suit to train participant to walk with different level of assistance.

  • Epidural StimulationDevice

    Also called ES

    lumbo-sacral epidural simulation at the beginning of the study.

  • Resistance TrainingProcedure or surgery

    Also called RT

    Using two forms of resistance training to increase muscle size. The first form includes seated leg extension exercise for 12 weeks followed by a second form that includes sit-to-stand exercise using participant's body weight.

  • delayed-ESDevice

    lumbo-sacral epidural simulation starting 6 months after the beginning of the study.

  • no-Resistance trainingProcedure or surgery

    Also called no-RT

    The participants will perform 24 weeks of passive movement or passive stretching from seated position.

Study groups in NCT04782947
Study groupRoleWhat they receive
EAW+ES+RTExperimentalThe exoskeletal assisted walking with epidural simulation and resistance training (EAW+ES+RT) group will undergo 6 months of supervised EAW +ES (3X per week) followed by additional 6 months of EAW+ES (3X per week) and progressive RT twice weekly (2X per week). In the EAW+ES+RT group, RT will be administered for 12 weeks using an open kinematic chain approach of applying surface NMES and ankle weights followed by 12 weeks twice weekly of gradually using the implanted ES to perform sit-to-stand approach (i.e. using their body weights to load the exercising muscles in a closed kinematic fashion).
Receives: Device: Exoskeletal assisted walking; Device: Epidural Stimulation; Procedure: Resistance Training
EAW+ delayed-ES +no-RTExperimentalThe control exoskeletal assisted walking with delayed epidural simulation and without resistance training (EAW+ delayed-ES +no-RT) group will enroll in 6 months of EAW without ES (3X per week) and then this will be followed by additional 6 months (3x per week) of EAW+ES (i.e., delayed entry approach) without conducting RT and will perform either passive movement of passive stretching (2X per week).
Receives: Device: Exoskeletal assisted walking; Device: delayed-ES; Procedure: no-Resistance training

What is being measured

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

  1. Change in 10-meter over ground walking-speed

    The investigators will measure the speed of walking and the time elapsed during 10 meter distance.

    Measured: Baseline to 12 months

  2. Change in EMG Pattern

    The investigators will record muscle activity from the major lower extremity muscle groups.

    Measured: Baseline to 12 months

Secondary outcomes (3)

  1. Changes in Systolic and Diastolic Blood Pressure

    The investigators will measure resting and walking blood pressure on continuous basis

    Measured: Baseline to 12 months

  2. Changes in regional fat mass

    body composition will be measured using dual energy x-ray absorptiometry

    Measured: Baseline to 12 months

  3. Change in Oxygen uptake

    measuring whole oxygen uptake during 6-minute walking test

    Measured: baseline and every 6 months for 12 months

Timeline

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

  1. First posted4 Mar 2021
  2. Study start3 Feb 2021
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

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 2/3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04782947
Sponsor's protocol ID
SC190107
Acronym
REST-SCI
Status last verified
Dec 2025
First submitted
26 Feb 2021
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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 2/3 study testing Exoskeletal assisted walking, Epidural Stimulation and Resistance Training in people with Spinal Cord Injuries, run by United States Department of Defense 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 3 inclusion and 14 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 2 Jan 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

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 Ashraf S Gorgey, PhD (804675500 ext. 3386, ashraf.gorgey@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 10-meter over ground walking-speed (time frame: Baseline to 12 months). 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 NCT04782947, which also lists 1 linked publication.

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 2 Jan 2026.

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