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).
NCT#04697472, www.clinicaltrials.gov
Study Overview
The purpose of this pivotal study is to evaluate the safety and effectiveness of non-invasive electrical spinal stimulation (ARC Therapy) therapy administered by the LIFT System (ONWARD, Inc., Lexington, MA, USA, henceforth referred as “The Sponsor”) for restoration of upper extremity function in individuals with chronic tetraplegia when compared to rehabilitation therapy, the current standard of care. Additionally, prospective data on quality of life and autonomic function improvements will be captured as secondary and/or observational endpoints.
What will happen during the study
If you decide to take part in this study, you will be asked to:
- Complete at least 4 months of Occupational Therapy Sessions
- 2 months without stimulation
- 2 months with transcutaneous spinal stimulation
- Sessions will be anywhere from 2-5 times per week
- Assessments will occur at 1 month intervals
- Receive Transcutaneous Spinal Stimulation
- Complete clinical assessments and share your medical health history and information
Inclusion criteria
Subjects must meet all of 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
- GRASSP-Prehension score ≥10 or GRASSP-Strength score ≥30
- Minimum 12 months post-injury
- If prescribed anti-spasticity or pain medications, must be at stable dose for at least 4 weeks prior to commencing study procedures
- Capable of providing informed consent
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
- History of additional neurologic disease such as stroke, multiple sclerosis, traumatic brain injury, etc.
- Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)
- Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
- Received Botulinum toxin injections in their upper extremity, neck or hand within 6 months prior to enrollment
- Has urinary tract infection or any of the following issues in the upper extremity or the cervical spine region at the time of enrollment: painful musculoskeletal dysfunction unrelated to SCI, unhealed fracture, contracture, pressure sore
- Breakdown in skin area that will come into contact with electrodes
- Presence of syringomyelia as confirmed by an MRI
- Currently undergoing treatment for cancer or has been in remission for less than 2 years
- Received stem cell treatment within the past two years prior to enrollment
- Prior nerve or tendon transfer procedure in the upper extremities
- Total baclofen dose >30 mg per day
- 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
- Has undergone a prior course of spinal stimulation therapy directed at UE improvement
-
In the opinion of the investigators, the study is not safe or appropriate for the participant and/or the subject is unlikely to return for the follow-up visits per the protocol