Neuromodulation Techniques for Spinal Cord Injury

Overseen By Robert Trainer, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Must not be taking: Anticoagulants, Antiplatelets, Insulin, others

Disqualifiers: Neurological injury, Fractures, 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: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help people with spinal cord injuries (SCI) stand and walk better. It combines spinal cord stimulation with robotic exoskeleton suits to enhance physical abilities and overall health. The study includes two groups: one using exoskeleton training with transspinal stimulation (EAW+TS) and the other with epidural stimulation (EAW+SCES). Men who have experienced a motor complete spinal cord injury at T10 or above and cannot move below the injury are suitable candidates. 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 SCI rehabilitation.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anti-coagulants or anti-platelet agents like aspirin unless you can safely stop them. It's best to discuss your specific medications with the trial team.

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

A previous study found that percutaneous spinal cord epidural stimulation (SCES) is a practical and safe method to help people with spinal cord injuries regain movement. SCES is generally well-tolerated, and reports show it can aid movement without causing major side effects.

For the EAW+TS treatment, research indicates that combining trans-spinal stimulation with exoskeleton training is safe. One study safely used repeated sessions to improve movement in people with spinal cord injuries.

Both treatments, EAW+SCES and EAW+TS, have shown promise in past research as safe and well-tolerated options for people with spinal cord injuries. Participants in previous studies did not report major safety issues with these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for spinal cord injury because they offer innovative approaches to rehabilitation. Unlike traditional therapies that focus mainly on physical therapy and medication, these treatments utilize advanced neuromodulation techniques. EAW+TS combines exoskeleton-assisted walking with transspinal stimulation, potentially enhancing nerve function and muscle control over time. Meanwhile, EAW+SCES pairs exoskeleton training with epidural stimulation, which aims to directly activate neural circuits in the spinal cord. These approaches could lead to significant improvements in mobility and quality of life for patients with spinal cord injuries.

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

This trial will compare two neuromodulation techniques for spinal cord injury. Research has shown that spinal cord epidural stimulation (SCES) combined with exoskeleton-assisted walking (EAW), which participants in one arm of this trial will receive, can help people with spinal cord injuries (SCI) regain movement. Studies have found that this method improves control over movements and supports heart health. Meanwhile, participants in another arm of this trial will receive exoskeleton training with trans-spinal stimulation (EAW+TS), which has increased physical activity and may reduce other health problems related to SCI. An analysis of several studies found that wearable exoskeletons significantly improve movement ability in people with SCI. Both methods show promise in enhancing movement and overall health for those with spinal cord injuries. ^{2 4 6 7 8}

Who Is on the Research Team?

Ashraf Gorgey, PhD PT

Principal Investigator

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Are You a Good Fit for This Trial?

This trial is for males aged 18-70 with traumatic motor complete spinal cord injury (SCI) at T10 level or above. They must have specific motor deficits, functional limb range of motion, and pass safety assessments like the Modified Ashworth Scale. Excluded are those with other neurological injuries, unhealed fractures, severe scoliosis or contractures that prevent exoskeleton use, certain implanted devices, low bone density scores, untreated severe conditions such as hypertension or diabetes.

Inclusion Criteria

I am a man aged 18-70 with a severe spinal cord injury above T10.

You will have a test to check your spinal cord function, and only those with severe motor deficits below the level of the injury will be included.

My muscle stiffness has been checked for safety before starting rehab.

Exclusion Criteria

You have a pacemaker or defibrillator implanted in your body.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exoskeleton Training

Participants undergo 3 months of exoskeleton training

12 weeks

3 sessions per week

Randomized Treatment

Participants are randomized to either EAW+SCES or EAW+TS for 6 months

24 weeks

3 sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Measurements at 3-month intervals

What Are the Treatments Tested in This Trial?

Interventions

• EAW+SCES
• EAW+TS

Trial Overview The study tests two rehabilitation techniques for SCI: one combines an exoskeleton suit with spinal cord epidural stimulation (EAW+SCES), and the other pairs the suit with transspinal stimulation (EAW+TS). The goal is to improve standing and walking abilities while reducing health issues related to SCI.

How Is the Trial Designed?

Group I: EAW+TS Experimental Treatment 1 Intervention

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

Group II: EAW+SCES Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11942695/

Epidural Stimulation and Resistance Training (REST-SCI) for ... Conclusions: Percutaneous SCES appears to be a feasible and safe rehabilitation approach for the restoration of motor function in persons with SCI. The ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04241250

NCT04241250 | Neuromodulation Techniques After SCI Spinal cord epidural stimulation (SCES) exhibits the rehabilitation potential of restoring locomotion in individuals with SCI when combined with intensive ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1112853/full

Effects of percutaneously-implanted epidural stimulation on ... These results demonstrate that SCES intended to facilitate walking may also enhance cardiovascular autonomic control and attenuate spasticity.

4. nature.com nature.com/articles/s41467-023-37845-7

A case study of percutaneous epidural stimulation to ... Spinal cord epidural stimulation (SCES) may modulate spinal cord neural networks to enhance multiple functions after motor complete spinal cord ...

5. withpower.com withpower.com/trial/phase-24b8c

Epidural Stimulation + Resistance Training for Spinal Cord Injury Spinal cord epidural stimulation (SCES) combined with exoskeletal-assisted walking (EAW) showed promising results in enhancing motor control for a person ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40142643/

Epidural Stimulation and Resistance Training (REST-SCI ... We determine the effects of exoskeleton-assisted walking [EAW] + epidural stimulation [ES] + resistance training [RT] on volitional motor ...

7. mdpi.com mdpi.com/2077-0383/14/6/1829

Epidural Stimulation and Resistance Training (REST-SCI) ... Percutaneous SCES appears to be a feasible and safe rehabilitation approach for the restoration of motor function in persons with SCI.

8. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.789422/full

Exoskeleton Training and Trans-Spinal Stimulation for ... Exoskeleton-assisted walking (EAW) may be one way to improve physical activity for adults with SCI and potentially alleviate secondary health complications.