Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
NCT Number: NCT02592668
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.
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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Rochester, Minnesota, 55905, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Medtronic Restore ULTRA 97712
Time frame: Approximately 50 weeks after implantation
Time frame: Approximately 50 weeks after implantation
Time frame: Approximately 50 weeks after implantation
Time frame: Approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Time frame: baseline, approximately 50 weeks after implantation
Mayo Clinic
Other
A Feasibility Study: Epidural Stimulation to Enable Volitional Movement After Chronic Complete Paralysis in Humans.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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