Vagus Nerve Stimulation Paired With Upper Extremity Rehabilitation for Chronic Stroke: Real-World Implementation and Outcomes.

Objective: This initiative aimed to assess real-world implementation and outcomes of a paired vagus nerve stimulation (VNS) program at AdventHealth Sports Medicine and Rehabilitation, part of the AdventHealth Central Florida system. Design: Case series of stroke patients who were implanted with a US Food and Drug Administration-approved vagus nerve stimulator and subsequently underwent at least 6 weeks of paired VNS therapy. Setting: Ten outpatient therapy clinics in central Florida. Participants: In total, 35 participants (21 men, 14 women), at least 6 months post ischemic stroke with moderate to severe upper extremity deficits. The average age was 59.2 (± SD, 13.9) years, and participants were 3.7 (± SD, 3.5) years poststroke. The mean baseline Fugl-Meyer assessment upper extremity (FMA-UE) test score averaged 30.4 (± SD, 10.2) points. Interventions: All patients were implanted with a vagus nerve stimulator and received VNS paired with outpatient occupational therapy focused on high-repetition task practice for a period of at least 6 weeks. Additionally, patients engaged in self-initiated use of VNS paired with daily tasks outside of the therapy clinic for periods of 30 minutes up to 8 times per day. Main Outcome Measures: FMA-UE test score, box and block test, and patient-specific functional scale were tested at baseline and after 6 weeks of paired VNS sessions. For program implementation, success was measured by the number of neuro-specialized occupational therapists fully trained and the number of therapy clinics in the AdventHealth Central Florida system trained and able to offer paired VNS sessions. Results: After the period of in-clinic therapy, the average FMA-UE test score improved by 10.8 (± SD, 5.4) points, with 28 of 35 (80%) participants classified as responders based on the FMA-UE test score's minimal clinically important difference of ≥6 points. The average box and block test score change was 4.5 blocks/min (± SD, 2.9), with 10 of 23 meeting the minimal detectable change of 5.5 blocks. In just over 2 years of program implementation, 84% (21/25) of all neuro-specialized occupational therapists in AdventHealth Sports Medicine and Rehabilitation clinics are fully trained, and 10 out of 10 neuro-focused outpatient clinics are now prepared to refer and offer paired VNS sessions. Conclusions: VNS paired with rehabilitation therapy in patients with chronic ischemic stroke resulted in meaningful functional improvements aligned with individual patient goals in a real-world practice setting. Our results support findings from the pivotal VNS-REHAB (Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke): a randomised, blinded, pivotal, device trial and provide evidence for the feasibility of paired VNS program implementation in clinical practice.