Clinical Trial Summary

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Phase

N/A

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Funding Agency/Sponsor

Industry

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Disease

Spine

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Enrollment Eligibility

Key Inclusion Criteria:
Subjects must meet all the following criteria:
1. At least 22 years old and no older than 75 years old at the time of enrollment
2. Non-progressive cervical spinal cord injury from C2-C8 inclusive
3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C,
or D
4. Indicated for upper extremity training procedures by subject's treating physician or a
physical therapist
5. Minimum 12 months post-injury
6. Capable of providing informed consent
Key Exclusion Criteria:
Subjects must not meet any of the following criteria:
1. Has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the
Investigator
2. Has any unstable or significant medical condition that is likely to interfere with
study procedures or likely to confound study endpoint evaluations like severe
neuropathic pain, depression, mood disorders or other cognitive disorders
3. Has been diagnosed with autonomic dysreflexia that is severe, unstable, and
uncontrolled
4. Requires ventilator support
5. Has an autoimmune etiology of spinal cord dysfunction/injury
6. Spasms that limit the ability of the subjects to participate in the study training as
determined by the Investigator
7. Breakdown in skin area that will come into contact with electrodes
8. Has any active implanted medical device
9. Pregnant, planning to become pregnant or currently breastfeeding
10. Concurrent participation in another drug or device trial that may interfere with this
study
11. In the opinion of the investigators, the study is not safe or appropriate for the
participant

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