Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord

Inclusion Criteria

• 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 - 65 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.

Exclusion Criteria

• Currently involved in another rehabilitation training study.
• Lower motor neuron injury revealed in the upper limbs.
• Stabilization hardware in the cervical spine, preventing implantation of ESS system.
• Active pressure sores, wounds, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including contractures in the upper and lower extremities).
• Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: ventilator dependence, cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing).
• Intrathecal baclofen pump therapy for spasticity.
• Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months which would result in absence of muscle tone and thus preclude response to electrical stimulation therapy.
• Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
• Clinically significant depression, psychiatric disorders, or ongoing drug abuse.
• Any reason the PI or treating physician may deem as harmful to the participant or inappropriate for the participant to enroll or continue in the study.
• Body Mass Index (BMI) over 30.
• Pregnancy.