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

4 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+