Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 60Years
All Genders
NCT04782947

Epidural Stimulation and Resistance Training After SCI

Led by United States Department of Defense · Updated on 2026-01-02

20

Participants Needed

1

Research Sites

277 weeks

Total Duration

On this page

Sponsors

U

United States Department of Defense

Lead Sponsor

C

Central Virginia VA Health Care System

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Epidural Stimulation and Resistance Training After SCI

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 to 60 years, male or female, with traumatic motor complete spinal cord injury at or above level T10 confirmed by EMG and neurological exam
  • Knee extensors must respond to standard surface neuromuscular electrical stimulation
  • Participants must have American Spinal Injury Classification (AIS) grade A or B indicating motor deficit below injury level
Not Eligible

You will not qualify if you...

  • Neurological injuries other than spinal cord injury, including cauda equina or distal conus injuries
  • Unhealed fractures in upper or lower limbs
  • Severe scoliosis or joint contractures preventing exoskeleton use
  • Untreated or uncontrolled high blood pressure or severe orthostatic hypotension
  • Cardiovascular disease, uncontrolled diabetes, pressure sores stage 3 or higher, or urinary tract infection
  • Unable to fit in the device
  • Use of anti-coagulant or anti-platelet medications that cannot be stopped
  • Implanted pacemakers or defibrillators
  • Bone density scans with T-scores less than -2.5 or specific low hip/knee bone density
  • Severe spasticity or limited joint range of motion
  • Severe pressure ulcers on trunk, pelvis, or limbs
  • History of psychiatric conditions that conflict with study goals
  • Any condition judged by investigators to increase risk or prevent safe participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States, 23249

Actively Recruiting

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Research Team

A

Ashraf S Gorgey, PhD

CONTACT

R

Robert Trainer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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