NCT04782947

Epidural Stimulation and Resistance Training After SCI

Epidural Stimulation and Resistance Training for Overground Locomotion After Spinal Cord Injury

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: United States Department of Defense · Federal
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Spinal cord epidural stimulation (ES) is a neuromodulation modality that can facilitate standing, stepping and walking with and without assistive devices in individuals with SCI, however; ES must be accompanied with locomotor training that at present requires a labor-intensive commitment from multiple well-trained personnel using specialized treadmill equipment. Exoskeletal assisted walking (EAW) on the other hand can be safely and efficiently used for ambulation after SCI in combination with ES without the use of other specialized equipment and multiple personnel. The investigators demonstrated that 12-weeks of EAW+ ES resulted in volitional stepping, with improved temporal and rhythmic electromyography (EMG) patterns and speed and with a reduction in EAW assistance to 35%. Unfortunately, EAW+ES does not appear to effectively restore lean mass below the level of injury, which impacts proprioceptive feedback to the spinal locomotor centers. Thus, in addition the investigators have demonstrated that 16-weeks of electrically-evoked resistance training (RT) resulted in robust muscle hypertrophy of the paralyzed knee and hip extensor muscle groups. Therefore, this proposal leverages these research programs by addressing two major gaps; 1) the use of combination EAW+ES as an activity-dependent plasticity tool for restoration of over ground locomotion and 2) enhancement of muscle quality using RT to provide afferent leverage for neuromodulation techniques. Specific Aims: 1. To determine the impact of 12 months of EAW+ES+RT on 10-meter over ground walking-speed, number of EAW unassisted steps and EMG patterning compared to 12-months of EAW+ delayed-ES +no-RT (control group). 2. To determine the impact of 12-months of EAW+ES+RT on blood pressure, total and regional body composition, oxygen uptake as well as anabolic and inflammatory biomarkers compared to the control group. 3. To determine the impact of 12-months of EAW+ES+RT on parameters of bladder filling and emptying as measured by urodynamic studies compared to the control group.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Exoskeletal assisted walking	Exoskeletal assisted walking includes the use of robotic suit to train participant to walk with different level of assistance.
DEVICE	Epidural Stimulation	lumbo-sacral epidural simulation at the beginning of the study.
PROCEDURE	Resistance Training	Using two forms of resistance training to increase muscle size. The first form includes seated leg extension exercise for 12 weeks followed by a second form that includes sit-to-stand exercise using participant's body weight.
DEVICE	delayed-ES	lumbo-sacral epidural simulation starting 6 months after the beginning of the study.
PROCEDURE	no-Resistance training	The participants will perform 24 weeks of passive movement or passive stretching from seated position.

Timeline

• Start date: 2021-02-03
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2021-03-04
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study