NCT04105296

Epidural Stimulation After Spinal Cord Injury

Epidural Stimulation for Locomotion After Spinal Cord Injury

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: McGuire Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the current study is to determine the effects of applying epidural stimulation (ES) on motor control recovery in Veterans with SCI. The intervention will be accompanied with the use of a powered exoskeleton (EKSO®) for 6 months to facilitate standing and to produce step-like movement in persons with chronic motor complete (AIS A or B) SCI and level of injury below C5 . Walking speed, distance, muscle activation pattern as measured by surface EMG and walking parameters including stand-up time, walking time, distance will be considered primary outcome variables. Cardiovascular performance, as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments will also be measured. The effects of training (ES+EKSO) on , and speed of walking will also be evaluated.

Detailed description

Five veterans with chronic motor complete SCI (AIS A or B) will be recruited to participate in the current trial. The primary objective is to determine how implantation of an epidural stimulator can help to control movement in the leg muscles to stand and perform stepping. Participants will be trained using a robotic suit and parallel bars. The procedure of using epidural stimulation with the robotic suit is experimental. The participant will be scheduled to perform temporary implantation followed by permanent implantation. Seven days later, two 8-electrode arrays of Vectris lead will be implanted in an operating room. The research team will be responsible for helping the participants to trigger the paralyzed muscles from supine and sitting using for 5 days per week. Participants would be required to come for study visits twice daily for 2 hours per day. Each visit will last approximately 1 hour in the morning and 1 hour in the evening. During these visits, participants will practice walking with a robotic suit for 30-60 minutes followed by overground walking between parallel bars, or with a walker or crutches.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	EKSO+ES	6 months of exoskeleton training with epidural stimulation.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2019-09-26
• Last updated: 2019-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study