A Multi-Center Clinical Trial in Individuals With Spinal Cord Injury

Specific Aim 1: Evaluate the effectiveness of a combined intervention utilizing dAIH and
massed practice upper extremity training on arm and hand function in individuals with
incomplete tetraplegia.

Specific Aim 2: Evaluate the effectiveness of a combined intervention utilizing dAIH therapy
and robotic rehabilitation device-administered upper-extremity training on arm and hand
function in persons with incomplete tetraplegia.

Inclusion:

1. History of a non-progressive spinal cord injury, at or below C2, and at or above T1.

2. Between the ages of 18 - 75 years.

3. At least 6 months since onset of spinal cord injury.

4. Demonstrate voluntary motor activation in hand muscles, with a score of at least a 2
on at least one of the Prehension Ability grasp patterns of the GRASSP assessment
(cylindrical grasp, lateral key pinch, and tip to tip pinch), on at least one upper
extremity.

5. Ability to understand and the willingness to sign an informed consent.

6. At least a 10% change in isometric elbow strength above baseline, after a single bout
of Acute Intermittent Hypoxia (AIH), during screening.

Exclusion:

1. Diagnosed with any of the following medical conditions: congestive heart failure,
cardiac arrhythmias, uncontrolled hypertension, uncontrolled diabetes mellitus,
chronic obstructive pulmonary disease, emphysema, severe asthma, previous myocardial
infraction, or known carotid/intracerebral artery stenosis.

2. Women who are currently pregnant/nursing or planning on becoming pregnant.

3. Individuals with a tracheostomy or who utilize mechanical ventilation.

4. Individuals who are currently enrolled in another interventional research study or in
therapy related to upper extremity function.

5. Participants will be excluded if they have had a botulinum toxin injection to upper
extremity musculature within the last 3 months. Participants will need to refrain from
upper extremity botulinum toxin injections for the duration of the study. If
participants wean off antispasticity medications to successfully complete the
responsiveness to AIH screening session, they will need to refrain from the
medications for the duration of the study.

6. Documented sleep apnea.

7. Orthopedic injuries or surgeries that would impact an individual's ability to use the
upper extremity.

8. Traumatic brain injury or other neurological conditions that would impact the study.

9. Blood hemoglobin levels less than 10g/dL.