Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

This study is to determine if non-invasive electrical stimulation of the spinal cord can
help improve hand and arm function in people with paralysis who suffered a cervical spinal
cord injury. The investigators hypothesize that this stimulation can revive spared function
in the spinal cord of individuals who are clinically paralyzed, but who have some remaining
connections between the brain and spinal cord. Our research has demonstrated that modifying
the activation state of the spinal cord or awakening the spinal cord can benefit people with
paralysis years after a spinal cord injury. This method and device have not yet been
approved by the FDA for the treatment of paralysis and are under investigation. This study
if successful will help provide further evidence that could be use to gain FDA approval.

Inclusion Criteria: ASIA C

- Spinal cord injury 1 or more years prior

- Non progressive SCI at C7 or higher

- Half of key muscles below neurological level having a motor score of less than 2/5

- Ability to commit to home exercises and 12 week participation

- Stable medical condition without cardiopulmonary disease or dysautonomia that would
contraindicate participation in upper extremity rehabilitation or testing activities

- Not dependent on ventilation support

- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary
tract infection that might interfere with upper extremity rehabilitation or testing
activities

- No clinically significant depression or ongoing drug abuse

- Adequate social support network to be able to participate in weekly training and
assessment sessions for the duration of the 12 week study period

- No current anti-spasticity regimen

- Must not have received botox injections in the prior six months

- Be unable to use upper extremity for functional tasks

Exclusion Criteria:

- Pregnancy

- No functional segmental reflexes below the lesion