NL-OMON51027
Completed
Phase 3
Clinical assessment of upper extremity performance in individuals with spinal cord injury using the LIFT System to deliver non-invasive electrical spinal stimulation (ARC Therapy) - The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ONWARD Medical, Inc.
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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