StudyFinder

The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury

Recruiting

To provide pilot evidence to the FDA for the LIFT System (a transcutaneous spinal cord stimulator) that the system is safe, effective, and evaluate potential benefits. This is a multisite industry sponsored study (GTX Medical, Inc., Lexington, MA).

I'm interested

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

Device: LIFT System

Chronic Spinal Cord Injury

SCI, Tetraplegia, ARC Therapy

Leslie Morse, DO - rehablab@umn.edu
N/A
NCT04697472
See this study on ClinicalTrials.gov

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