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)
- Conditions
- SCITetraplegia10041543
- Registration Number
- NL-OMON51027
- Lead Sponsor
- ONWARD Medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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. Presence of syringomyelia as confirmed by an MRI
12.Total baclofen dose >30 mg per day
13. In the opinion of the investigators, the study is not safe or appropriate
for the participant
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: Observational data regarding the incidence of serious adverse events<br /><br>(SAEs) related to the use of the study device and treatment procedures will be<br /><br>reported.<br /><br><br /><br>Effectiveness: The primary effectiveness outcome measure will test the<br /><br>hypothesis that a majority of the subjects will experience clinically<br /><br>significant improvement in selected strength and functional performance metrics<br /><br>after treatment with ARC Therapy administered by the LIFT System and FTP. A<br /><br>subject will be considered a treatment responder if she/he reports clinically<br /><br>relevant improvements in at least one outcome each in the Strength and Function<br /><br>domains as follows:<br /><br><br /><br>Strength: ISNCSCI-UEMS, GRASSP-Strength, CUE-T, Pinch force, Grasp<br /><br>force<br /><br>Function: GRASSP-Prehension, CUE-T</p><br>
- Secondary Outcome Measures
Name Time Method