From the School of Health and Rehabilitation Sciences, Department of Physical Therapy, Massachusetts General Hospital Institute for Health Professions, Boston (T.J.K.)Division of Physical Therapy, Department of Rehabilitation Medicine, University of Minnesota, Minneapolis (T.J.K., C.N.P., D.K.K.)MicroTransponder, Inc, Austin, TX (D.P., C.N.P., B.T., N.D.E.)Department of Physical Medicine and Rehabilitation, University of Texas Health Science Center at Houston McGovern Medical School (G.E.F., N.Y.)The NeuroRecovery Research Center at TIRR Memorial Hermann (G.E.F., N.Y.)Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas (P.S., J.G.W.)Tx Biomedical Device Center at The University of Texas at Dallas (J.G.W.)Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary, and Life Sciences, Queen Elizabeth University Hospital, University of Glasgow, United Kingdom (D.A.D., J.D.)Department of Neurology, University of California, Irvine (S.C.C.).
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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.