Epidural Stimulation After Neurologic Damage

Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new
and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain
with established medical device platforms. The purpose of this study is to investigate and
establish the use of SCS for volitional movement. Specifically, establishing the
disinhibitory effect of SCS in a greater population with inherent greater variability.

In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to
explore the parameter space of the spinal cord stimulator platforms in order to optimize
stimulation settings for patients through the creation of a clinical decision support system
(CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also
begins to explore the effects of SCS on cardiovascular function, urinary function,
psychiatric outcomes, and quality of life, which all offer significant potential for patients
suffering from chronic spinal cord injury.

Inclusion Criteria:

- 22 years of age or older

- Able to undergo the informed consent/assent process

- Stable, motor-complete paraplegia

- Discrete spinal cord injury between C6 and T10

- ASIA A or B Spinal Cord Injury Classification

- Medically stable in the judgement of the principal investigator

- Intact segmental reflexes below the lesion of injury

- Greater than 1 year since initial injury and at least 6 months from any required
spinal instrumentation

- Willing to attend all scheduled appointments

Exclusion Criteria:

- Diseases and conditions that would increase the morbidity and mortality of spinal cord
injury surgery (e.g. cardiopulmonary issues)

- Inability to withhold antiplatelet/anticoagulation agents perioperatively

- Significant dysautonomia that would prohibit rehabilitation or assisted standing or
any history of CVA or MI associated with autonomic dysreflexia. A single tilt table
test with syncope, presyncope, or SBP < 50 or >200.

- Other conditions that would make the subject unable to participate in
testing/rehabilitation in the judgement of the principal investigator

- Current and anticipated need for opioid pain medications or pain that would prevent
full participation in the rehabilitation program in the judgement of the principal
investigator

- Clinically significant mental illness in the judgement of the principal investigator

- Botulinum toxin injections in the previous 6 months

- Volitional movements present during EMG testing in bilateral lower extremities

- Unhealed spinal fracture

- Presence of significant contracture

- Presence of pressure ulcers

- Recurrent urinary tract infection refractory to antibiotics

- Current Pregnancy