Kimberley, T. J. et al. (2018) Vagus nerve stimulation paired with upper limb rehabilitation after chronic stroke. Stroke, 49(11), pp. 2789-2792. (doi: 10.1161/strokeaha.118.022279) (PMID:30355189)
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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.
Item Type: | Articles |
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Additional Information: | The trial was funded by MicroTransponder, Inc. |
Status: | Published |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | Dawson, Professor Jesse and Dickie, Dr David Alexander |
Authors: | Kimberley, T. J., Pierce, D., Prudente, C. N., Francisco, G. E., Yozbatiran, N., Smith, P., Tarver, B., Engineer, N. D., Dickie, D. A., Kline, D. K., Wigginton, J. G., Cramer, S. C., and Dawson, J. |
College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health |
Journal Name: | Stroke |
Publisher: | Lippincott Williams & Wilkins |
ISSN: | 1524-4628 |
Copyright Holders: | Copyright © 2018 American Heart Association, Inc. |
First Published: | First published in Stroke 49(11):2789-2792 |
Publisher Policy: | Reproduced in accordance with the copyright policy of the publisher |
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