Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke

A Blinded Randomized Pilot Study

Teresa J. Kimberley, PT, PhD; David Pierce, MSEE; Cecília N. Prudente, PT, PhD; Gerard E. Francisco, MD; Nuray Yozbatiran, PT, PhD; Patricia Smith, PhD, PT; Brent Tarver, BSEE; Navzer D. Engineer, PhD; David Alexander Dickie, PhD; Danielle K. Kline, DPT; Jane G. Wigginton, MD, MSCS; Steven C. Cramer, MD; Jesse Dawson, MD

Disclosures

Stroke. 2018;49(11):2789-2792. 

In This Article

Abstract and Introduction

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.

Introduction

Impaired use of the upper limb is one of the most common symptoms after stroke, and improving upper limb function is a priority for many patients.[1] Clinical trials of increased dose of upper extremity task-specific training have been disappointing.[2] This suggests new interventions are needed to maximize poststroke motor recovery.[3]

Vagus nerve stimulation (VNS) paired with movement has been shown to drive task-specific plasticity in the motor cortex in rodent models and improve forelimb function after experimental stroke.[4] In our first-in-human, randomized, controlled, open clinical trial, VNS paired with upper limb rehabilitation was safe and feasible in people with upper limb deficit at least 6 months after ischemic stroke.[5]

The purpose of this pilot study was to further assess safety, feasibility, and efficacy of VNS paired with upper limb rehabilitation in chronic ischemic stroke, with blinded, sham VNS control.

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