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

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ClinicalTrials.gov Identifier: NCT04697472
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
ONWARD Medical, Inc.

Tracking Information
First Submitted Date  ICMJE December 4, 2020
First Posted Date  ICMJE January 6, 2021
Last Update Posted Date July 9, 2021
Actual Study Start Date  ICMJE January 8, 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2021)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
  • 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.
  • 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 at least 50% of the subjects will experience clinically significant improvement in at least two out of the five UE performance metrics (defined as therapy responders) after treatment with ARC Therapy administered by the LIFT System and Functional Task Practice (FTP).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2021)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Spinal Cord Injury
Intervention  ICMJE Device: LIFT System
The LIFT System delivers the ARC Therapy to improve upper extremity function in individuals with tetraplegia.
Study Arms  ICMJE 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.
Intervention: Device: LIFT System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2021)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: www.ONWD.com +31 (0)40 288 2830 uplift@onwd.com
Listed Location Countries  ICMJE Canada,   Netherlands,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04697472
Other Study ID Numbers  ICMJE DOC1622
Pro00046320 ( Other Identifier: Advarra )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ONWARD Medical, Inc.
Study Sponsor  ICMJE ONWARD Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Edelle Field-Fote, PT, PhD Shepherd Center - Crawford Research Institute
Principal Investigator: Chet Moritz, PT, PhD University of Washington
PRS Account ONWARD Medical, Inc.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP