Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord
The goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training. This is an investigational study. The device used for epidural spinal stimulation (ESS) to deliver spinal stimulation is called the CoverEdgeX 32 Surgical Lead system. This device is approved by the Food and Drug Administration (FDA) for the treatment of severe pain and to manage chronic pain when other treatments have not been effective. In this study, the device is considered an investigational device because it is not approved for use in the treatment of spinal cord injury
• All participants must provide a signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female aged 22 - 70 years old.
• Must provide documentation from personal primary treating physician that reports stable medical condition.
• Able to passively range bilateral upper extremities within normal mobility parameters including:
‣ greater than 90 degrees of shoulder flexion and 20 degrees of shoulder extension;
⁃ greater than 120 degrees of elbow flexion and reach elbow extension of approximately 150 degrees;
⁃ neutral wrist position reaching a minimum of 70 degrees of movement (between flexion and extension;
⁃ ability to passively flex and extend fingers.
• Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes.
• Six (6) months to 20 years post spinal cord injury.
• Non-progressive spinal cord injury.
• Chronic SCI with neurologic level of injury as defined by ISNCSCI AIS A, B, or C.
• Neurological level of injury above T2.
• Eligible for fMRI per safety questionnaire.
• Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study.