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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
2
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.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Duration of time for which subject can sit unassisted on the edge of a mat table
Time frame: Approximately 50 weeks after implantation
Assessment of volitional movement of lower limbs
Time frame: Approximately 50 weeks after implantation
Subject's ability to coordinate stepping on a treadmill will be measured using biomechanical and electrophysiological analyses
Time frame: Approximately 50 weeks after implantation
Duration of time for which subject can stand weight bearing with minimal assistance provided as needed.
Time frame: Approximately 50 weeks after implantation
Change in volitional movement restoration via NeuroRecovery scale
Time frame: baseline, approximately 50 weeks after implantation
Change of bladder function, as measured by the Neurogenic Bladder Symptom Score questionnaire
Time frame: baseline, approximately 50 weeks after implantation
Change in sexual function as measured by the Sexual Function Questionnaire
Time frame: baseline, approximately 50 weeks after implantation
Change in body thermoregulatory capacity as measured by thermoregulatory sweat testing
Time frame: baseline, approximately 50 weeks after implantation
Change in lean body mass
Time frame: baseline, approximately 50 weeks after implantation
Change in bone density
Time frame: baseline, approximately 50 weeks after implantation
Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
Time frame: baseline, approximately 50 weeks after implantation
Change in sitting balance via functional reach test
Time frame: baseline, approximately 50 weeks after implantation
Change in spasticity via Ashworth spasticity test
Time frame: baseline, approximately 50 weeks after implantation
Change in ability of performing basic activities of daily life via spinal cord independence measure
Time frame: baseline, approximately 50 weeks after implantation
Change in total body fat
Time frame: baseline, approximately 50 weeks after implantation
Change in bowel function as measured by the Neurogenic Bowel Dysfunction Score questionnaire
Time frame: baseline, approximately 50 weeks after implantation
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