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 : April 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Spinal Cord Injury||Device: LIFT System||Not Applicable|
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 -
- Relevance to UE function,
- Capture improvements in performance, and
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||February 2022|
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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697472
|Contact: www.ONWD.com||+31 (0)40 288 firstname.lastname@example.org|
|United States, Colorado|
|Englewood, Colorado, United States, 80113|
|Contact: Candace Tefertiller, PT, DPT, PhD, NCS|
|Contact: Patricia Bartelt, BS|
|United States, Georgia|
|Shepherd Center- Crawford Research Institute||Recruiting|
|Atlanta, Georgia, United States, 30303|
|Contact: Edelle Field-Fote, PT, PhD|
|Contact: Allison McIntyre, MOT, OT/L|
|United States, Massachusetts|
|INSPIRE Laboratory, Spaulding Hospital||Recruiting|
|Cambridge, Massachusetts, United States, 02138|
|Contact: Randy D Trumbower, PT, PhD|
|Contact: Stella Barth, BA|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55441|
|Contact: Leslie Morse, DO|
|Contact: Rob Wudlick, BS|
|Rochester, Minnesota, United States, 55905|
|Contact: Kristin Zhao, PhD|
|Contact: Tyson Scrabeck, BS|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Chet Moritz, PT, PhD|
|Contact: Fatma Inanici, MD, PhD email@example.com|
|Principal Investigator:||Edelle Field-Fote, PT, PhD||Shepherd Center - Crawford Research Institute|
|Principal Investigator:||Chet Moritz, PT, PhD||University of Washington|