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

NCT04697472 | Completed DMC FDA Device

• 2 other identifiers: DOC1622Pro00046320
• Study Type: interventional
• Target: 65
• Locations: 4 countries
• Sites: 14

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.

Conditions

Chronic Spinal Cord Injury

Keywords

SCI; Tetraplegia; ARC Therapy

Outcome Measures

Primary Outcomes (2)

• Incidence of serious adverse events (SAEs)

  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.

  Through completion of the study, an average of 16 months

• Number of participants with change in upper extremity strength and function

  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).

  Through completion of the study, an average of 16 months

Secondary Outcomes (1)

• Superiority of combined FTP and ARC Therapy with LIFT vs. FTP alone.

  Through completion of the study, an average of 16 months

Study Arms (1)

Functional task practice (FTP) followed by FTP + ARC Therapy

EXPERIMENTAL

Clinic-based functional task practice (FTP) for two months followed by FTP + ARC Therapy for an additional 2 months.

Device: LIFT System

Interventions

LIFT System DEVICE

The LIFT System delivers the ARC Therapy to improve upper extremity function in individuals with tetraplegia.

Functional task practice (FTP) followed by FTP + ARC Therapy

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all 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
• Minimum 12 months post-injury
• Capable of providing informed consent

You may not qualify if:

• 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
• Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
• Breakdown in skin area that will come into contact with electrodes
• 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
• In the opinion of the investigators, the study is not safe or appropriate for the participant

Sponsors & Collaborators

• ONWARD Medical, Inc.: lead

Study Sites (14)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Miller School of Medicine, The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

Shepherd Center- Crawford Research Institute

Atlanta, Georgia, 30303, United States

Location

INSPIRE Laboratory, Spaulding Hospital

Cambridge, Massachusetts, 02138, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55441, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

Thomas Jefferson University/Magee Rehabilitation Hospitals

Philadelphia, Pennsylvania, 19107, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

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

Vancouver, British Columbia, V5Z 1M9, Canada

Location

KITE Research Institute /University Health Network

Toronto, Ontario, M4G 3V9, Canada

Location

Sint Maartenskliniek, Department of Rehabilitation

Nijmegen, Gelderland, 6574, Netherlands

Location

Reade, Centre for Rehabilitation and Rheumatology

Amsterdam, North Holland, 1054 HW, Netherlands

Location

Queen Elizabeth National Spinal Injuries Unit

Glasgow, G51 4TF, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 29877852 BACKGROUND

• 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.

  PMID: 24244094 BACKGROUND

• Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20.

  PMID: 38769431 DERIVED

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edelle Field-Fote, PT, PhD

  Shepherd Center - Crawford Research Institute

  PRINCIPAL INVESTIGATOR

• Chet Moritz, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: January 6, 2021
• Study Start: January 8, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 13, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); CA (2); US (9); GB (1)