Vagus Nerve Stimulation Paired With Rehabilitation Yields Sustained Upper Limb Recovery in Individuals With Stroke

According to post hoc analysis of the VNS-REHAB clinical trial (NCT03131960), vagus nerve stimulation (VNS) paired with upper extremity (UE) rehabilitation showed significant improvements in UE impairment, activity, and quality-of-life (QoL) measures in individuals who experienced ischemic stroke.

The study included 108 participants from 19 sites in the United States and the United Kingdom with chronic ischemic stroke and moderate-to-severe UE impairment who received 18 sessions (3 times per week for 6 weeks) of in-clinic intensive task-specific rehabilitation and 90 days of self-initiated home-based exercise with either active (0.8 mA for 0.5 s) or sham (0.0 mA) VNS. Participants and researchers were unblinded after the initial 90-day outcome assessment, and control participants crossed over to receive an additional 18 sessions of in-clinic intensive task-specific rehabilitation therapy with active VNS. All participants subsequently performed 1 year of home-based exercises paired with self-initiated active stimulation. Researchers assessed outcomes through 1 year using the Fugl-Meyer Assessment for UE (FMA-UE), Wolf Motor Function Test (WMFT), and various patient-reported participation and QoL scales.

74 participants (69%; mean age 59.6 years) completed 1 year of follow-up, with pooled data reported. At 1 year, compared with baseline:

• FMA-UE scores improved by 5.23 points (95% CI, 4.08 to 6.39; P<.001).
• WMFT scores improved by 0.50 (95% CI, 0.41 to 0.59; P<.001).
• Motor Activity Log–Quality of Movement scores increased by 0.64 (95% CI, 0.46 to 0.82; P<.001).
• Motor Activity Log–Amount of Use scores increased by 0.64 (95% CI, 0.46 to 0.82; P<.001).
• Stroke Impact Scale–Activities of Daily Living scores improved by 7.43 (95% CI, 5.09 to 9.77; P<.001).
• Stroke Impact Scale–Hand scores improved by 17.89 (95% CI, 14.16 to 21.63; P<.001).
• EQ-5D improved by 5.76 (95% CI, 2.08 to 9.45; P<.05).
• Stroke-Specific QoL scores improved by 0.29 (95% CI, 0.19 to 0.39; P<.001).

These results demonstrate that paired VNS, which is Food and Drug Administration (FDA)-approved for the treatment of individuals with chronic UE impairment after ischemic stroke, is a beneficial treatment option for individuals with ischemic stroke who experience UE limitations.