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

  • STATUS
    Recruiting
  • End date
    Feb 18, 2022
  • participants needed
    65
  • sponsor
    ONWARD Medical, Inc.
Updated on 18 July 2021

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.

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.

Details
Condition Chronic Spinal Cord Injury
Treatment LIFT System
Clinical Study IdentifierNCT04697472
SponsorONWARD Medical, Inc.
Last Modified on18 July 2021

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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