Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke: A Blinded Randomized Pilot Study. Issue 11 (November 2018)

• Record Type: Journal Article
• Authors: Kimberley, Teresa J.; Pierce, David; Prudente, Cecília N.; Francisco, Gerard E.; Yozbatiran, Nuray; Smith, Patricia; Tarver, Brent; Engineer, Navzer D.; Alexander Dickie, David; Kline, Danielle K.; Wigginton, Jane G.; Cramer, Steven C.; Dawson, Jesse
• Is Part Of: Stroke. Volume 49:Issue 11(2018)
• Publication Date: 2018-11
• Subjects: motor cortex -- neuromodulation -- plasticity -- rehabilitation -- stroke -- upper extremity -- vagus nerve; Cerebrovascular disease -- Periodicals; Cerebral circulation -- Periodicals; 616.81
• DOI: 10.1161/STROKEAHA.118.022279
• Languages: English
• ISSNs: 0039-2499

Abstract

Abstract : Background and Purpose—: We assessed safety, feasibility, and potential effects of vagus nerve stimulation (VNS) paired with rehabilitation for improving arm function after chronic stroke. Methods—: We performed a randomized, multisite, double-blinded, sham-controlled pilot study. All participants were implanted with a VNS device and received 6-week in-clinic rehabilitation followed by a home exercise program. Randomization was to active VNS (n=8) or control VNS (n=9) paired with rehabilitation. Outcomes were assessed at days 1, 30, and 90 post-completion of in-clinic therapy. Results—: All participants completed the course of therapy. There were 3 serious adverse events related to surgery. Average FMA-UE scores increased 7.6 with active VNS and 5.3 points with control at day 1 post–in-clinic therapy (difference, 2.3 points; CI, −1.8 to 6.4; P =0.20). At day 90, mean scores increased 9.5 points from baseline with active VNS, and the control scores improved by 3.8 (difference, 5.7 points; CI, −1.4 to 11.5; P =0.055). The clinically meaningful response rate of FMA-UE at day 90 was 88% with active VNS and 33% with control VNS ( P <0.05). Conclusions—: VNS paired with rehabilitation was acceptably safe and feasible in participants with upper limb motor deficit after chronic ischemic stroke. A pivotal study of this therapy is justified. Clinical Trial Registration—: URL:https://www.clinicaltrials.gov . Unique identifier: NCT02243020. Abstract : Supplemental Digital Content is available in the text.