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.