Spinal Stimulation to Improve Upper Extremity Recovery in the Home - The long-term goal of this work is to improve upper extremity (UE) function, independence, and quality of life for individuals with cervical spinal cord injury (SCI) (target population). The primary objective of this study is to conduct a pilot randomized controlled trial (RCT) in the home that is safe, feasible, and tolerable using non-invasive transcutaneous spinal stimulation (TSS) in combination with UE functional task-specific practice (FTP). We will collaborate with a stakeholder advisory board (SAB), including individuals with SCI, caregivers, clinicians, researchers, and industry partners, to refine and finalize the protocol based on the SAB's understanding of the needs and circumstances of individuals with SCI. We will investigate whether eight weeks of UE FTP+TSS improves outcomes of UE function and strength in individuals who are less than 12 months post-injury compared to natural recovery (waitlist control group); we will compare these outcomes when TSS is on versus when TSS is off; we will evaluate satisfaction, usability, and perceived change with training; and we will explore qualitatively the experiences of individuals and caregivers participating in this training in their home. Therefore, the central hypothesis of this proposal is that non-invasive TSS with UE FTP in the home is safe, feasible, and tolerable, plus it has the potential to yield greater UE recovery within the first-year post-injury than natural recovery. The data generated from this pilot RCT will inform a future efficacy study's statistical power and methodological design (product). This research explicitly addresses NIDILRR’s mission to maximize health and function among people with disabilities, and it evaluates an intervention that could support community living and participation.
