Status:
COMPLETED
The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury
Lead Sponsor:
ONWARD Medical, Inc.
Conditions:
Chronic Spinal Cord Injury
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief Summary
The Up-LIFT Study is a prospective, single-arm study designed to evaluate the safety and effectiveness of non-invasive electrical spinal cord stimulation (ARC Therapy) administered by the LIFT System ...
Detailed Description
The primary endpoint of this pivotal study will report device related safety and changes in established metrics of upper extremity performance after treatment with the study device. To ensure that th...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04697472
Start Date
January 8 2021
End Date
September 13 2022
Last Update
September 16 2022
Active Locations (14)
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1
Craig Hospital
Englewood, Colorado, United States, 80113
2
Miller School of Medicine, The Miami Project to Cure Paralysis
Miami, Florida, United States, 33136
3
Shepherd Center- Crawford Research Institute
Atlanta, Georgia, United States, 30303
4
INSPIRE Laboratory, Spaulding Hospital
Cambridge, Massachusetts, United States, 02138