In a retrospective single-health-system cohort, Paired VNS was associated with significant improvement in FMA-UE scores among 28 local completers, with findings directionally consistent with prior trial evidence.
FMA-UE scores improved for all 28 local completers who underwent Paired VNS therapy.
71.4% of local completers achieved a clinically meaningful response, defined as a ≥6-point improvement in FMA-UE.
88% of implanted patients completed the intended Paired VNS protocol within the health system.
Adverse events among the 32 implanted patients were limited, with one postoperative hematoma and one device explantation.
The study population consisted of adults with chronic ischemic stroke and persistent upper extremity deficits, with a median stroke chronicity of 3.0 years.
Chart-derived clinical notes provided illustrative context regarding individual changes in daily activities accompanying UE motor improvement in selected cases.
This research suggests that a treatment called Paired Vagus Nerve Stimulation (Paired VNS) — which combines mild electrical stimulation of the vagus nerve in the neck with arm rehabilitation exercises — may help people with long-term arm weakness after stroke regain meaningful motor function. In this study, 28 patients who had experienced a stroke on average 3 years prior completed an 18-session outpatient therapy program using an implanted device called Vivistim. Every single patient showed some improvement in arm movement as measured by a standardized clinical scale (the Fugl-Meyer Assessment), and about 71% improved enough to be considered a clinically meaningful change. The average improvement in arm motor scores was approximately 9.4 points, which exceeds the threshold researchers typically consider clinically significant. The treatment also appeared relatively safe in this group: out of 32 people who had the device implanted, one experienced a blood collection after surgery that resolved on its own, and one had the device removed after over a year due to a sensation of chest tingling. These results are consistent with what was found in earlier randomized controlled trials that led to the FDA approving this therapy in 2021. This research matters because recovery options for people with persistent arm weakness months or years after a stroke are very limited. This real-world study suggests that the benefits seen in controlled clinical trials may also be achievable in routine clinical practice settings, across multiple outpatient clinics. However, because this was a retrospective observational study without a control group, it cannot definitively prove that VNS caused the improvements — other factors, such as the rehabilitation exercises themselves, may have contributed. The authors note that findings are 'directionally consistent with prior trial evidence,' meaning this adds supportive but not conclusive real-world data.
Benitez R, Darling M, Zaorski P, Galligan Q, Maurer J, McNamara N, et al.. (2026). Upper extremity motor outcomes during paired vagus nerve stimulation in chronic ischemic stroke: a retrospective single-health-system cohort study.. Frontiers in neurology. https://doi.org/10.3389/fneur.2026.1872498