The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury (Up-LIFT)

• ClinicalTrials.gov Identifier: NCT04697472
• Recruitment Status: Completed
• First Posted: January 6, 2021
• Last Update Posted: September 16, 2022
• Sponsor: ONWARD Medical, Inc.
• Information provided by (Responsible Party): ONWARD Medical, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Spinal Cord Injury	Device: LIFT System	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: January 8, 2021
• Actual Primary Completion Date: June 30, 2022
• Actual Study Completion Date: September 13, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Functional task practice (FTP) followed by FTP + ARC Therapy; Clinic-based functional task practice (FTP) for two months followed by FTP + ARC Therapy for an additional 2 months.	Device: LIFT System; The LIFT System delivers the ARC Therapy to improve upper extremity function in individuals with tetraplegia.

Outcome Measures

Primary Outcome Measures :

1. Incidence of serious adverse events (SAEs) [ Time Frame: Through completion of the study, an average of 16 months ]
   Safety demonstrated through observational data regarding the incidence of serious adverse events (SAEs) related to the use of the study device and treatment procedures will be reported.
2. Number of participants with change in upper extremity strength and function [ Time Frame: Through completion of the study, an average of 16 months ]

   Change in upper extremity strength and function performance metrics after treatment with ARC Therapy administered by the LIFT System and Functional Task Practice (FTP) is assessed using ISNCSCI, GRASSP,CUE-T, pinch/grasp forces.

   The primary effectiveness outcome measure will test the hypothesis that a majority of the subjects will experience clinically significant improvement in UE performance metrics (defined as therapy responders) after treatment with ARC Therapy administered by the LIFT System and Functional Task Practice (FTP).

Secondary Outcome Measures :

1. Superiority of combined FTP and ARC Therapy with LIFT vs. FTP alone. [ Time Frame: Through completion of the study, an average of 16 months ]
   Superiority as demonstrated by statistically significant difference in the proportion of subjects reporting improvement between the two treatment groups.

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Colorado

Craig Hospital

Englewood, Colorado, United States, 80113

United States, Florida

Miller School of Medicine, The Miami Project to Cure Paralysis

Miami, Florida, United States, 33136

United States, Georgia

Shepherd Center- Crawford Research Institute

Atlanta, Georgia, United States, 30303

United States, Massachusetts

INSPIRE Laboratory, Spaulding Hospital

Cambridge, Massachusetts, United States, 02138

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55441

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, New York

James J. Peters VA Medical Center

Bronx, New York, United States, 10468

United States, Pennsylvania

Thomas Jefferson University/Magee Rehabilitation Hospitals

Philadelphia, Pennsylvania, United States, 19107

United States, Washington

University of Washington

Seattle, Washington, United States, 98195

Canada, British Columbia

International Collaboration on Repair Discoveries (ICORD), University of British Columbia

Vancouver, British Columbia, Canada, V5Z 1M9

Canada, Ontario

KITE Research Institute /University Health Network

Toronto, Ontario, Canada, M4G 3V9

Netherlands

Sint Maartenskliniek, Department of Rehabilitation

Nijmegen, Gelderland, Netherlands, 6574

Reade, Centre for Rehabilitation and Rheumatology

Amsterdam, Noord-Holland, Netherlands, 1054 HW

United Kingdom

Queen Elizabeth National Spinal Injuries Unit

Glasgow, United Kingdom, G51 4TF

Sponsors and Collaborators

ONWARD Medical, Inc.

Investigators

• Principal Investigator: Edelle Field-Fote, PT, PhD; Shepherd Center - Crawford Research Institute
• Principal Investigator: Chet Moritz, PhD; University of Washington

More Information

Publications:

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.

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.

• Responsible Party: ONWARD Medical, Inc.
• ClinicalTrials.gov Identifier: NCT04697472
• Other Study ID Numbers: DOC1622; Pro00046320 ( Other Identifier: Advarra )
• First Posted: January 6, 2021
• Last Update Posted: September 16, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by ONWARD Medical, Inc.:

SCI; Tetraplegia; ARC Therapy

Additional relevant MeSH terms:

Spinal Cord Injuries; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System