Vagus Nerve Stimulation Paired With Upper Extremity Rehabilitation for Chronic Stroke: Real-World Implementation and Outcomes.
Amanda Saylor, Laura Patrick, Chandan G Reddy and 1 others
PMID 41834814WHAT IT FOUND
In a case series of 35 chronic stroke patients, those receiving paired VNS therapy with occupational therapy showed an average 10.8-point improvement on upper extremity motor scores.
Most exceeded the minimal clinically important difference. However, without a control group, it is unclear if the VNS device or the intensive therapy drove these gains.
Key findings
01Patients improved an average of 10.8 points on the Fugl-Meyer Assessment for Upper Extremity after approximately 6 weeks of paired VNS therapy, with 28 of 35 patients meeting the minimal clinically important difference threshold.
02The therapy involved 90-minute sessions three times per week, combining task-specific training with adjunctive interventions such as functional electrical stimulation, strength training, and mobile arm supports.
03Patients were encouraged to use self-activated VNS at home for up to 4 hours daily, a practice not included in the initial FDA-approval trial, which may have contributed to the observed outcomes.
STILL TO COME
How it was doneWhat they foundWhat it means for OTs
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What it does not show
The study was a case series without a control group, so it is impossible to determine if the improvements were due to the VNS stimulation, the intensive occupational therapy, or the combination of both. Outcome assessors were not blinded, and in some cases, different therapists performed baseline and post-treatment testing, introducing potential bias. Secondary outcome measures (BBT and PSFS) were not consistently collected across all patients, with only 16 of 35 completing the PSFS and 23 of 35 completing the BBT. The results may not generalize to other settings, as the study was conducted in a single health system with a high concentration of neuro-specialized OTs and specific insurance scheduling advantages.
Declared interests
One author (A.S.) was a paid consultant for MicroTransponder, the manufacturer of the VNS device, from March 2023 to August 2025, and subsequently became a full-time employee of the company. The other authors declared no conflicts.
The easy way to misread this
Do not assume the VNS device alone caused the motor improvements. The patients received intensive occupational therapy with multiple adjunctive interventions (such as electrical stimulation and strength training) alongside the VNS, and the study lacked a control group to separate the effects of the device from the effects of the therapy.
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