The University of Texas at Dallas
The purpose of this study is to evaluate the safety, feasibility, and preliminary effectiveness of the ReWire system, which delivers vagus nerve stimulation (VNS) paired with lower limb rehabilitation to improve gait in individuals with mobility impairments resulting from chronic, incomplete spinal cord injury (SCI).
A randomized, multi-center, double-blinded sham-control early feasibility trial of participants implanted with the ReWire System for spinal cord injury (SCI) with and open label extension. During the pre-therapy phase, participants will undergo informed consent, baseline assessment, pre-operative evaluation, surgical implantation of the ReWire system, post-surgical assessment, and randomization. Following post-surgical assessment, participants will be block randomized in a 1:1 ratio to either active CLV (Immediate start group) or sham stimulation (Delayed start group) for the double-blind pha…
Inclusion Criteria: 1. Ability to provide signed and dated informed consent. 2. Willingness and ability to comply with all study procedures and protocol requirements for the duration of the study. 3. Age 18 to 64 years. 4. Chronic, non-penetrating, motor incomplete spinal cord injury \[Association Impairment Scale (AIS) grade C or D\] occurring ≥12 months prior to enrollment, resulting in impairment in lower limb function. 5. Ambulatory with residual gait impairment attributable to spinal cord injury. 6. Self-selected gait speed of \< 0.8 m/s as measured by the 10 meter walk test. 7. Score of…
The participants in this group will be implanted with the ReWire system and receive CLV in the double-blind phase
The participants in this group will be implanted with the ReWire system and receive Sham in the double-blind phase