SCI Tetraplegia
Conditions
Interventions
None listed
Sponsors
ONWARD Medical, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion 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 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Observational data regarding the incidence of serious adverse events (SAEs) related to the use of the study device and treatment procedures will be reported. Effectiveness: The primary effectiveness outcome measure will test the hypothesis that a majority of the subjects will experience clinically significant improvement in selected strength and functional performance metrics after treatment with ARC Therapy administered by the LIFT System and FTP. A subject will be considered a treatment responder if she/he reports clinically relevant improvements in at least one outcome each in the Strength and Function domains as follows: Strength: ISNCSCI-UEMS, GRASSP-Strength, CUE-T, Pinch force, Grasp force Function: GRASSP-Prehension, CUE-T | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: All adverse events (AEs) and SAEs in the study will be reported. Effectiveness: To capture meaningful improvements in established outcomes assessing upper extremity function, the following hierarchical testing will be carried out. These endpoints will be tested in descending order of importance through hierarchical testing as described in the Statistical Analysis Plan (SAP). - Superiority of combined MPT and ARC Therapy with LIFT vs. FTP alone as described by statistically significant difference in responder rates (comparison of change from enrollment baseline to end of FTP with the change from enrollment baseline to end of combined FTP and ARC Therapy with LIFT) - Quantitative comparison of individual performance metrics to establish superiority of FTP and ARC Therapy with LIFT compared to FTP alone: - Pinch force - GRASSP-Prehension - GRASSP-Strength - ISNCSCI-UEMS - ISNCSCI-Total sensory score - EQ-5D-5L - SCIM - WHOQOL-BREF | — |
Countries
Netherlands
Outcome results
None listed