Task-specific Epidural Stimulation Study

Experimental Design

The investigators will enroll, implant and complete the interventions in 36 research participants who have sustained a SCI in the proposed experiments. The investigators anticipate they will need to screen 108 potential research participants to enroll 36 individuals who will complete the study. This sample size will provide sufficient replication per study group (n=4) from which variance and effect size estimates for each study hypothesis can be calculated, and hypothesis tests conducted. The investigators will also select individuals to assure that there are a minimum of 25% (n=9) women to adequately represent the percentage in the SCI population. The investigators will study each cohort of patients comprehensively, and each individual will be allocated to the group interventions based on the method of minimization. Research participants will be randomized into group interventions. This novel approach of conducting repeated experiments with comprehensive assessments in a smaller cohort of patients, rather than a more traditional approach of including a large number of patients and focusing on a single outcome, will advance both clinical and scientific knowledge in this highly complex population. The investigators have found success with the smaller cohort approach because they can employ more rigorous, quantitative and sensitive outcomes that not only inform them about the potential clinical efficacy, but also provide further knowledge of the mechanisms of neural control of movement and other physiological mechanisms related to cardiovascular, respiratory, bladder, bowel and sexual function.

Group A:

• Vol-scES during voluntary leg movement training while sitting or lying supine (A1).
• CV-scES during sitting or lying supine (A2).

Group B:

• Vol-scES during voluntary leg movement training + Stand-ES during stand training (B1).
• CV-ES during sitting or lying supine + Stand-ES during stand training (B2).

Inclusion criteria

• At least 18 years of age
• Non-progressive spinal cord injury
• At least 2 years post injury
• Stable medical condition
• Unable to voluntarily move all individual joints of the legs
• Unable to stand independently
• Cardiovascular dysfunction including presence of persistent low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in a 24 hour period
• Urodynamic dysfunction including dyssynergia and/or inability to void voluntarily and/or low voiding capacity
• Respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes

Exclusion criteria

• Ventilator dependent
• Untreated painful musculoskeletal dysfunction, fracture or pressure sore
• Untreated psychiatric disorder or ongoing drug abuse
• Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury
• Bladder botox injections less than 12 months prior to implant
• Colostomy bag, urostomy
• Any implanted pump (i.e., baclofen pump, pain pump, etc)
• Ongoing nicotine use
• Pregnant at the time of enrollment or planning to become pregnant during the time course of the study