Epidural Stimulation + Resistance Training for Spinal Cord Injury

(REST-SCI Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ashraf S Gorgey, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: United States Department of Defense

Must not be taking: Anticoagulants, Antiplatelets

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for people with severe spinal cord injuries. It combines electrical stimulation, a robotic walking suit, and muscle-strengthening exercises to help them walk and improve muscle strength. Recent advancements have combined electrical stimulation with robotic exoskeletons to facilitate movement and improve motor recovery in individuals with spinal cord injuries. The goal is to make it easier for these individuals to move and improve their overall health.

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.

What data supports the effectiveness of the treatment Epidural Stimulation + Resistance Training for Spinal Cord Injury?

Research shows that epidural electrical stimulation (EES) can help improve motor function and enable voluntary control of muscle activity in people with spinal cord injuries. Additionally, combining EES with exoskeletal-assisted walking has shown potential in enhancing motor control and enabling unassisted steps in individuals with spinal cord injuries. ^{1 2 3 4 5}

Is epidural electrical stimulation safe for humans?

Epidural electrical stimulation has been studied for spinal cord injury and is generally considered safe, with safety being monitored through the incidence of adverse events in clinical trials. ^{1 2 3 6 7}

How does the treatment of Epidural Stimulation + Resistance Training for Spinal Cord Injury differ from other treatments?

This treatment is unique because it combines epidural electrical stimulation (EES) with resistance training to help restore movement and standing ability in people with spinal cord injuries. EES works by stimulating the spinal cord to activate muscle movements, even in those with severe paralysis, and when combined with resistance training, it can enhance motor control and muscle strength. ^{2 3 4 5 6}

Research Team

Ashraf S Gorgey, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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

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

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Epidural Stimulation (Device)
• Exoskeletal assisted walking (Device)
• Resistance Training (Procedure)

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.

Participant Groups

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 Canada for the following indications:

Approved in Canada 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+

Pete Hegseth

United States Department of Defense

Chief Executive Officer

Bachelor's degree in Political Science from Princeton University, JD from Harvard Law School

Lisa Hershman

United States Department of Defense

Chief Medical Officer since 2021

MD from Uniformed Services University of the Health Sciences

Central Virginia VA Health Care System

Collaborator

Trials

1

Recruited

20+

Findings from Research

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]

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 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 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Hypertrophy of paravertebral muscles after epidural electrical stimulation shifted: A case report. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation of evoked muscle potentials induced by epidural spinal-cord stimulation in paralyzed individuals. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Epidural stimulation: comparison of the spinal circuits that generate and control locomotion in rats, cats and humans. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Epidural electrical stimulation to facilitate locomotor recovery after spinal cord injury. [2022]

7. India 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. [2022]