BACKGROUND AND PURPOSE: Recent animal studies demonstrate that vagus nerve stimulation (VNS) paired with movement induces movement-specific plasticity in motor cortex and improves forelimb function after @entity64 . We conducted a randomized controlled clinical pilot study of VNS paired with rehabilitation on upper-limb function after @entity385 . METHODS: Twenty-one @entity1 with @entity385 >6 months before and moderate to severe @entity3140 were randomized to VNS plus rehabilitation or rehabilitation alone. Rehabilitation consisted of three 2-hour sessions per week for 6 weeks, each involving >400 movement trials. In the VNS group, movements were paired with 0.5-second VNS. The primary objective was to assess safety and feasibility. Secondary end points included change in upper-limb measures (including the Fugl-Meyer Assessment-Upper Extremity). RESULTS: Nine @entity1 were randomized to VNS plus rehabilitation and 11 to rehabilitation alone. There were no serious adverse device effects. One @entity1 had transient @entity3746 and @entity1282 after implantation. Five had minor adverse device effects including @entity390 and taste disturbance on the evening of therapy. In the intention-to-treat analysis, the change in Fugl-Meyer Assessment-Upper Extremity scores was not significantly different (between-group difference, 5.7 points; 95% confidence interval, -0.4 to 11.8). In the per-protocol analysis, there was a significant difference in change in Fugl-Meyer Assessment-Upper Extremity score (between-group difference, 6.5 points; 95% confidence interval, 0.4 to 12.6). CONCLUSIONS: This study suggests that VNS paired with rehabilitation is feasible and has not raised safety concerns. Additional studies of VNS in adults with @entity64 will now be performed. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01669161.

Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After XXXX .

@entity1 :: ('9606', 'Species') :: ['participants', 'patient'] @entity64 :: ('MESH:D020521', 'Disease') :: ['stroke', 'chronic stroke'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity3140 :: ('MESH:D038062', 'Disease') :: ['upper-limb impairment'] @entity1282 :: ('MESH:D003680', 'Disease') :: ['dysphagia'] @entity3746 :: ('MESH:D014826', 'Disease') :: ['vocal cord palsy'] @entity385 :: ('MESH:D002544', 'Disease') :: ['ischemic stroke']
@entity385 :: (MESH:D002544,Disease) :: ['Ischemic Stroke']
