Epidural Stimulation + Resistance Training for Spinal Cord Injury

(REST-SCI Trial)

Overseen By Lance Goetz, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: United States Department of Defense

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Neurological injury, Unhealed fracture, Severe scoliosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with spinal cord injuries stand, step, and potentially walk again. It combines epidural stimulation (ES) with resistance training (RT) to improve muscle strength, heart health, and bladder control. The trial compares two groups: one using ES with a special robot suit and RT, and the other using ES with the robot suit but no RT. Suitable candidates have a spinal cord injury at or above the lower back and have knee muscles that respond to stimulation. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in spinal cord injury recovery.

Will I have to stop taking my current medications?

The trial requires participants to stop taking anti-coagulants or anti-platelet agents, including aspirin, unless they cannot do so for medical reasons.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that epidural stimulation (ES) has been tested in various settings. In studies with animals that have spinal cord injuries, ES improved movement. Human trials demonstrated that ES enhanced trunk stability. These findings suggest that ES is generally well-tolerated.

For resistance training (RT), studies have found significant benefits for people with spinal cord injuries. RT increased muscle strength, improved body composition, and enhanced heart and metabolic health in trials lasting 6 to 12 weeks. This suggests that RT is generally safe for this group.

The trial under consideration is in its later stages (Phase 2/3), indicating that the treatment has already shown some safety in earlier trials. While no treatment is without risk, current evidence supports that both ES and RT are likely to be well-tolerated in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of epidural stimulation (ES) and resistance training (RT) for spinal cord injury because it offers a new approach to rehabilitation. Unlike standard therapies that might focus on physical therapy and medications, this method uses ES to directly stimulate the spinal cord, potentially enhancing the body's ability to regain movement. The integration of resistance training aims to strengthen muscles more effectively by progressively challenging them, either through surface neuromuscular electrical stimulation (NMES) or by using body weight in a sit-to-stand approach. This trial could reveal new insights into improving mobility and muscle function for individuals with spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that epidural stimulation (ES) can help people with spinal cord injuries regain movement. In one study, four participants using ES were able to stand independently. Another study found that ES improves trunk stability, which is crucial for mobility. Resistance training (RT) has increased muscle strength and improved heart health in people with spinal cord injuries. RT is also linked to better muscle mass and strength, aiding overall recovery. This trial will compare two approaches: one group will receive a combination of exoskeletal-assisted walking, ES, and RT, while another group will receive exoskeletal-assisted walking with delayed ES and no RT. Together, ES and RT offer promising benefits for improving movement and health in those with spinal cord injuries. ^{1 4 5 6 7}

Who Is on the Research Team?

Ashraf S Gorgey, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with traumatic motor complete spinal cord injury (SCI) at T10 level or above. They must have intact neural circuitry below the SCI as confirmed by tests, and fit specific criteria like having certain muscle responses. People with severe bone density loss, unhealed fractures, major cardiovascular issues, untreated severe spasticity or pressure sores, among other exclusions, cannot participate.

Inclusion Criteria

My leg muscles respond to electrical stimulation after my spinal cord injury.

I am 18-60 years old with a spinal cord injury above T10, confirmed by tests.

I have a spinal injury classified as AIS A or B with motor issues below the injury.

Exclusion Criteria

You cannot physically fit into the device for any reason.

You have a history of mental health issues that could interfere with the study goals.

I have a severe pressure ulcer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants undergo 6 months of exoskeletal assisted walking with epidural stimulation (EAW+ES) 3 times per week

24 weeks

3 visits per week (in-person)

Extended Treatment

Participants continue with 6 months of EAW+ES and add resistance training (RT) twice weekly

24 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in EMG patterns, walking speed, and other health metrics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Stimulation
• Exoskeletal assisted walking
• Resistance Training

Trial Overview The study is testing whether using an 'ES Robot Suit' combined with resistance training can improve movement control in people who are paralyzed due to SCI. It compares those who use the suit with epidural stimulation alone to those who also do resistance training for better muscle quality and overall health.

How Is the Trial Designed?

Group I: EAW+ES+RT Experimental Treatment 3 Interventions

The 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).

Group II: EAW+ delayed-ES +no-RT Experimental Treatment 3 Interventions

The 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).

Epidural Stimulation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Epidural Stimulation for:

• Spinal cord injury rehabilitation
• Motor function recovery
• Autonomic function recovery

Approved in Canada as Epidural Stimulation for:

• Spinal cord injury rehabilitation
• Motor function recovery
• Autonomic function recovery

Approved in European Union as Epidural Stimulation for:

• Spinal cord injury rehabilitation
• Motor function recovery
• Autonomic function recovery

Who Is Running the Clinical Trial?

United States Department of Defense

Lead Sponsor

Trials

940

Recruited

339,000+

Central Virginia VA Health Care System

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

Epidural stimulation (ES) of the lumbosacral spinal cord can selectively activate different leg muscles in individuals with complete motor paralysis, indicating its potential for facilitating movement after spinal cord injuries.

The study, involving three participants, found that the effectiveness of ES in evoking muscle responses depended on stimulation parameters and body weight conditions, suggesting that weight-bearing can reorganize spinal circuitry for improved motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation of evoked muscle potentials induced by epidural spinal-cord stimulation in paralyzed individuals. Sayenko, DG., Angeli, C., Harkema, SJ., et al.[2021]

Epidural stimulation has evolved from primarily suppressing pain in spinal cord injury patients to facilitating posture and locomotion, showing promise in helping individuals with severe spinal cord injuries regain movement.

Research indicates that the lumbosacral region of the spinal cord contains the necessary circuitry for normal locomotion, and combining epidural stimulation with pharmacological treatments and step training enhances locomotor patterns, suggesting a potential pathway for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural stimulation: comparison of the spinal circuits that generate and control locomotion in rats, cats and humans. Gerasimenko, Y., Roy, RR., Edgerton, VR.[2022]

This study will evaluate the effectiveness of EMG-induced rehabilitation treatment in enhancing muscle recovery in 20 patients with spinal cord injury (SCI) who are receiving epidural electrical stimulation, comparing it to conventional rehabilitation methods.

The trial will monitor various outcomes, including muscle strength, quality of life, and safety over a 6-month period, aiming to improve rehabilitation strategies for SCI patients post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of electromyography-induced rehabilitation treatment after epidural electrical stimulation for spinal cord injury: study protocol for a prospective, randomized, controlled trial. Sun, XP., Shi, JJ., Bao, Y., et al.[2022]

Spinal cord epidural stimulation (SCES) combined with exoskeletal-assisted walking (EAW) showed promising results in enhancing motor control for a person with complete C7 spinal cord injury, reducing the need for swing assistance from 100% to 35% over 12 weeks.

The approach led to 573 unassisted steps, indicating improved muscle activation and potential for greater independence in movement, suggesting that SCES with EAW could be a practical rehabilitation method for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. Gorgey, AS., Gill, S., Holman, ME., et al.[2021]

Epidural electrical stimulation of the lumbosacral spinal cord has been shown to improve locomotion and standing in various preclinical models with severe spinal cord injuries, indicating its potential as a therapeutic intervention.

The review highlights that while the stimulation shows promise, the exact mechanisms by which it enhances sensorimotor functions are still not fully understood, which poses challenges for its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural electrical stimulation to facilitate locomotor recovery after spinal cord injury. Audet, J., Lecomte, CG.[2022]

Epidural electrical stimulation (EES) has been shown to improve motor function in patients with chronic spinal cord injury, but its effects on paravertebral muscles had not been previously recognized.

In a reported case, hypertrophy of the paravertebral muscles occurred after an electrode shift in a patient with spinal cord injury, suggesting that EES may also influence muscle growth in this area, indicating a potential new avenue for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertrophy of paravertebral muscles after epidural electrical stimulation shifted: A case report. Li, S., Rong, H., Hao, Z., et al.[2022]

Epidural electrical stimulation (EES) of the lumbosacral spinal cord allowed a patient with chronic traumatic paraplegia to achieve significant motor control, including voluntary movement of muscles for specific tasks and rhythmic movements within just 2 weeks of therapy.

This case demonstrates the potential of EES to enable independent standing and controlled movements in patients with severe spinal cord injuries, highlighting its efficacy as a promising intervention for restoring motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia. Grahn, PJ., Lavrov, IA., Sayenko, DG., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7710539/

Epidural Electrical Stimulation of the Lumbosacral Spinal Cord ... Epidural Electrical Stimulation of the Lumbosacral Spinal Cord Improves Trunk Stability During Seated Reaching in Two Humans With Severe ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8374568/

Epidural electrical stimulation for spinal cord injury - PMC In multiple animal models of spinal cord injury, epidural electrical stimulation of the spinal cord has demonstrated a recovery of motor function.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07105878

Epidural Electrical Stimulation in Spinal Cord Injury The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function ...

4. spj.science.org spj.science.org/doi/10.34133/cbsystems.0314

Epidural Electrical Stimulation for Functional Recovery in ... This study confirms the promising therapeutic effects of EES in SCI. EES combined with PT provides a potential approach for functional recovery in patients ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2025.2517935?src=

Spinal epidural electrical stimulation for the recovery of ... With epidural stimulation, four subjects gained better control of standing full weight bearing (without assistance). Four (80%) subjects were ...

6. frontiersin.org frontiersin.org/journals/systems-neuroscience/articles/10.3389/fnsys.2020.569337/full

Epidural Electrical Stimulation of the Lumbosacral Spinal ... We characterize the effects of ES on seated reaching performance in two participants with chronic, complete loss of motor and sensory functions below thoracic- ...

7. mayo.edu mayo.edu/research/clinical-trials/cls-20167853

Spinal Cord Injury Epidural Stimulation Epidural electrical stimulation (EES) of the spinal cord has been shown to restore function after spinal cord injury (SCI).