Long-Term Outcomes of Vagus Nerve Stimulation Paired With Upper Extremity Rehabilitation After Stroke.

BACKGROUND

Persistent upper extremity (UE) impairment is common after stroke. Durable treatment benefits for chronic ischemic stroke are needed. The purpose of this report is to determine the long-term effects of vagus nerve stimulation paired with rehabilitation on impairment, activity, and participation in people with UE impairment after ischemic stroke.

METHODS

This is a post hoc analysis of data from the VNS-REHAB (A Pivotal Randomized Study Assessing Vagus Nerve Stimulation [VNS] During Rehabilitation for Improved Upper Limb Motor Function After Stroke) randomized clinical trial. Here, we report unblinded, partial crossover, and pooled 1-year outcomes. Initially, 108 participants across 19 sites with chronic ischemic stroke and moderate-to-severe UE impairment were enrolled in VNS-REHAB. Participants received 18 sessions of in-clinic intensive task-specific rehabilitation and 3 months of self-initiated home-based exercise with either real (active) or sham (control) vagus nerve stimulation. Thereafter, Control participants crossed over to receive in-clinic therapy paired with active stimulation. All participants performed home-based exercises paired with self-initiated active stimulation for 1 year. The Fugl-Meyer Assessment UE, Wolf Motor Function Test, and participation outcomes were assessed through 12 months.

RESULTS

Seventy-four participants (69%; 51 male; age, mean±SD, 59.6±8.9) completed 1-year follow-up and provided pooled data through 1 year. At 1 year, compared with baseline, there were improvements in impairment (Fugl-Meyer Assessment UE, 5.23 [95% CI, 4.08-6.39]; <0.001) activity (Wolf Motor Function Test, 0.50 [95% CI, 0.41-0.59]; <0.001) and patient-reported outcomes (Motor Activity Log-Quality of Movement: 0.64 [95% CI, 0.46-0.82], <0.001; Motor Activity Log-Amount of Use: 0.64 [95% CI, 0.46-0.82], <0.001; Stroke Impact Scale-Activities of Daily Living: 7.43 [95% CI, 5.09-9.77], <0.001; Stroke Impact Scale-Hand: 17.89 [95% CI, 14.16-21.63], <0.001; EQ-5D: 5.76 [95% CI, 2.08-9.45], <0.05; and Stroke Specific-Quality of Life: 0.29 [95% CI, 0.19-0.39], <0.001) compared with baseline.

CONCLUSIONS

People treated with paired vagus nerve stimulation maintained improvements in UE impairment, activity, participation, and quality-of-life measures at 1 year. Paired vagus nerve stimulation is a Food and Drug Administration-approved, beneficial treatment option for long-term benefit in individuals with chronic UE limitations after ischemic stroke.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03131960.