Clinical trial NCT04697472: The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Spinal Cord Injury
Keywords: SCI
Tetraplegia
ARC Therapy
Lead sponsor: ONWARD Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 65
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 to treat upper extremity functional deficits in people with chronic tetraplegia.

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 the benefits realized in the study are directly attributable to the ARC Therapy, all enrolled subjects will first undergo a guided, in-clinic conventional functional task practice (FTP) program lasting approximately two months to regain their upper extremity (UE) function. Performance gains realized during this wash-in period provide a subject specific control that reflects the limits of conventional functional task practice without stimulation (standard of care). At the conclusion of the wash-in period, subjects will complete pre-stimulation testing of UE function.

To test the additive benefit of training with stimulation, combined functional task practice and ARC Therapy will then be administered over a period of approximately two months using the LIFT System. Functional task practice will follow established rehabilitation protocols that are specific to the individual subject's specific needs and capabilities (Beekhuizen \& Field-Fote, Functional Task Practice versus Functional Task Practice with Stimulation: Effects on Upper Extremity Function and Cortical Plasticity in Individuals with Incomplete Cervical Spinal Cord Injury, 2005). Training will be graded to accommodate performance improvement over time, thus maximizing the potential benefit to subjects. Subjects will participate in up to 20 in-clinic training sessions per month. At the end of training period, the improvement in UE function will be measured and used to assess the progress of primary study endpoints.

The choice of primary outcome measures for this pivotal study is dictated by the following factors -

1. Safety,
2. Relevance to UE function,
3. Capture improvements in performance, and
4. Magnitude of changes that are clinically meaningful.

All performance metrics will be assessed at enrollment, at the completion of the wash-in period and at the end of the ARC Therapy assessment period. Subjects with clinically meaningful gains in multiple performance domains resulting from the ARC Therapy with LIFT will be considered responders. Additionally, gains during the wash-in (control) period will be compared to gains during the ARC Therapy with LIFT (test) period. Safety will be evaluated throughout the entire study through periodic monitoring and analysis of all reported adverse events.

Eligibility 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

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. In the opinion of the investigators, the study is not safe or appropriate for the participant

Primary outcomes:
measure: Incidence of serious adverse events (SAEs)
timeFrame: Through completion of the study, an average of 16 months
measure: Number of participants with change in upper extremity strength and function
timeFrame: Through completion of the study, an average of 16 months
Secondary outcomes:
measure: Superiority of combined FTP and ARC Therapy with LIFT vs. FTP alone.
timeFrame: Through completion of the study, an average of 16 months
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: Miami
country: United States
facility: Miller School of Medicine, The Miami Project to Cure Paralysis
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center- Crawford Research Institute
state: Georgia
city: Cambridge
country: United States
facility: INSPIRE Laboratory, Spaulding Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University/Magee Rehabilitation Hospitals
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Vancouver
country: Canada
facility: International Collaboration on Repair Discoveries (ICORD), University of British Columbia
state: British Columbia
city: Toronto
country: Canada
facility: KITE Research Institute /University Health Network
state: Ontario
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek, Department of Rehabilitation
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Reade, Centre for Rehabilitation and Rheumatology
state: Noord-Holland
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth National Spinal Injuries Unit
Study officials:
affiliation: Shepherd Center - Crawford Research Institute
name: Edelle Field-Fote, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Chet Moritz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.
citation: Hoffman L, Field-Fote E. Effects of practice combined with somatosensory or motor stimulation on hand function in persons with spinal cord injury. Top Spinal Cord Inj Rehabil. 2013 Fall;19(4):288-99. doi: 10.1310/sci1904-288.