NCT02592668

Spinal Cord Injury Epidural Stimulation

A Feasibility Study: Epidural Stimulation to Enable Volitional Movement After Chronic Complete Paralysis in Humans.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a feasibility study to test the use of epidural stimulation to restore volitional function previously lost due to spinal cord injury. Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic, have shown that direct electrical stimulation of the spinal cord increases the excitability of spared neuronal connections within the site of injury, thereby enhancing signal transmission and allowing recovery of previously lost volitional function. Recently, epidural electrical stimulation of the lumbosacral spinal cord in four individuals with spinal cord injury (SCI) has restored motor and autonomic function below the level of injury. Despite positive results, further translational research is needed to validate these findings. The goal of this proposal is to perform epidural stimulation to restore volitional function in patients with SCI. In two patients, we will implant an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Epidural Stimulator	Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.

Timeline

• Start date: 2016-01-04
• Primary completion: 2018-09-14
• Completion: 2019-02-11
• First posted: 2015-10-30
• Last updated: 2020-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study