Two-Year Retention of Benefits After Paired Vagus Nerve Stimulation in Stroke: Follow-Up of the VNS-REHAB Randomized Clinical Trial

Abstract

OBJECTIVES: Vagus nerve stimulation (VNS) paired with rehabilitation improves short-term upper extremity (UE) function in people with chronic ischemic stroke. Because sustained improvements are needed for people with stroke, we examined the long-term effects of Paired VNS on impairment, activity, participation, and quality of life. METHODS: This is a post hoc analysis of 2-year data of the triple-blind, sham-controlled, randomized VNS-REHAB pivotal trial. After receiving the full therapeutic protocol with either real (Active) or sham (Control) VNS, participants continued self-activated active stimulation for at least 2 years. The Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Wolf Motor Function Test (WMFT), participation, and quality of life outcomes were assessed at multiple time points. RESULTS: Pooled 2-year outcome data were available from 49 participants. At the 2-year point, FMA-UE scores improved 7.51 points (95% CI 5.80-9.22; p < 0.001), and WFMT scores improved 0.63 points (0.50-0.75; p < 0.001) from baseline. There were significant improvements from baseline in 5 of 7 participation and quality of life measures at 2 years. Improvements were retained at 3 years among a subset of participants (n = 16). DISCUSSION: The sustained improvements in UE impairment and function for at least 2 years make this an important treatment option for a defined subset of individuals with chronic arm and hand deficits after ischemic stroke. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov/study/NCT03131960.