The Up-LIFT Study of Non-Invasive ARC Therapy for Spinal Cord Injury
Condition: Chronic Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

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.
    

Intervention name(s): LIFT System
Intervention type(s): Device
Intervention description(s): The LIFT System delivers the ARC Therapy to improve upper extremity function in individuals with tetraplegia.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SCI; Tetraplegia; ARC Therapy