Two-Year Retention of Benefits After Paired Vagus Nerve Stimulation in Stroke

Q: What are the key findings of this study?

Paired vagus nerve stimulation with rehabilitation significantly improved upper extremity motor function, with an average FMA-UE score increase of 7.51 points from baseline at 2 years.

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Chronic ischemic stroke with upper extremity motor deficits (n=49). Intervention: Paired vagus nerve stimulation (VNS) with rehabilitation. Primary outcome: Change in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score from baseline at 2 years (MD 7.51, 95% CI 5.80-9.22, p=<0.001).

Q: What does this research mean for the field?

Vagus nerve stimulation paired with rehabilitation produces sustained improvements in upper extremity motor function and quality of life at two years post-treatment in chronic ischemic stroke patients. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To evaluate the long-term retention of upper extremity motor gains, daily activity, participation, and quality of life at 2 and 3 years following paired vagus nerve stimulation in individuals with chronic ischemic stroke.

Teresa J. Kimberley; Isha Vora; Steven C. Cramer; Steven L. Wolf; Jesse Dawson; for the VNS-REHAB Trial Group

doi:10.1212/wnl.0000000000218298

July 14, 2026NeurologyOpen Access

Two-Year Retention of Benefits After Paired Vagus Nerve Stimulation in Stroke

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Key result

Paired vagus nerve stimulation with rehabilitation boosts long-term upper extremity motor function by ~8 points.

MD +7.51
95% CI 5.80-9.22
P<0.001
n=49

Why the study?

Does paired vagus nerve stimulation with rehabilitation improve upper extremity motor function in patients with chronic ischemic stroke?

Key Points

To evaluate the long-term retention of upper extremity motor gains, daily activity, participation, and quality of life at 2 and 3 years following paired vagus nerve stimulation in individuals with chronic ischemic stroke.
Post hoc long-term analysis of the triple-blind, sham-controlled, randomized VNS-REHAB trial conducted across 19 sites in the United States and the United Kingdom (N=108; NCT03131960).
Participants with moderate-to-severe upper extremity deficits received 6 weeks of in-clinic rehabilitation paired with active or sham VNS, followed by self-activated home VNS therapy over 2 to 3 years.
Outcomes were assessed at 2 years (N=49) and 3 years (n=16) using the Fugl-Meyer Assessment-Upper Extremity (FMA-UE) and Wolf Motor Function Test-Functional Ability Scale (WMFT-FAS).
At 2 years, average FMA-UE and WMFT-FAS scores improved from baseline by 7.51 points (95% CI 5.80–9.22; p < 0.001) and 0.63 points (95% CI 0.50–0.75; p < 0.001), respectively.
Among the subset assessed at 3 years (n=16), improvements were retained with average baseline gains of 7.47 points (95% CI 4.84–10.11; p < 0.001) on the FMA-UE and 0.69 points (95% CI 0.50–0.89; p < 0.001) on the WMFT-FAS.

Study Design

Type

Cohort (n=49)

Blinding

Unblinded during long-term phase (originally triple-blind)

Randomization

Randomly assigned to active or sham VNS initially, then crossed over

Multicenter

Yes

Structured PICO

Does paired vagus nerve stimulation with rehabilitation improve upper extremity motor function in patients with chronic ischemic stroke?

P

Population

49 adults aged 22-80 with chronic ischemic stroke and upper extremity motor deficits, followed for 2 years after paired vagus nerve stimulation.

I

Intervention

Paired vagus nerve stimulation (VNS) with rehabilitation (6 weeks in-clinic followed by daily 30-minute self-activated home-based therapy) for 2 years.

O

Outcome

Change in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score from baseline at 2 years.surrogate

Main Result

Mean Difference: 7.51 (95% CI 5.8–9.22)

p-value: p=<0.001

Limitations

Lack of a control comparator during the long-term phase
Unblinded nature of the assessments during the long-term phase
Minimal data on the nature or frequency of participants' engagement in self-activated therapy during the second year
lack of a control comparator
unblinded nature of the assessments during the long-term phase
minimal data on nature or frequency of engagement in self-activated therapy during the second year

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Implication

Paired vagus nerve stimulation provides durable, clinically meaningful improvements in upper extremity motor function up to 2 years post-stroke.

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. 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.

Discussion

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Cite This Study

Kimberley et al. (2026) conducted a cohort in Chronic ischemic stroke with upper extremity motor deficits (n=49). Paired vagus nerve stimulation (VNS) with rehabilitation was evaluated on Change in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score from baseline at 2 years (MD 7.51, 95% CI 5.80-9.22, p=<0.001). Paired vagus nerve stimulation with rehabilitation significantly improved upper extremity motor function, with an average FMA-UE score increase of 7.51 points from baseline at 2 years.

synapsesocial.com/papers/6a59c5a7a58755010b4711c2 https://doi.org/10.1212/wnl.0000000000218298

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Two-Year Retention of Benefits After Paired Vagus Nerve Stimulation in Stroke

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Two-Year Retention of Benefits After Paired Vagus Nerve Stimulation in Stroke

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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