http://stroke.ahajournals.org/content/47/1/143.full?sid=44bf82cc-c46f-4cd0-bec3-1d782258960c
- Jesse Dawson, MD;
- David Pierce, MSEE;
- Anand Dixit, MD;
- Teresa J. Kimberley, PhD;
- Michele Robertson, BSc;
- Brent Tarver, BSEE;
- Omar Hilmi, FRCS;
- John McLean, PhD;
- Kirsten Forbes, MD;
- Michael P. Kilgard, PhD;
- Robert L. Rennaker, PhD;
- Steven C. Cramer, MD;
- Matthew Walters, MD;
- Navzer Engineer, PhD
+ Author Affiliations
- Correspondence to Jesse Dawson, MD, College of Medical, Veterinary and Life Sciences, Institute of Cardiovascular and Medical Sciences, Queen Elizabeth University Hospital, Glasgow G51 4TF, United Kingdom. E-mail jesse.dawson@glasgow.ac.uk
Abstract
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 stroke. We conducted a randomized controlled clinical
pilot study of
VNS paired with rehabilitation on upper-limb
function after ischemic stroke.
Methods—Twenty-one
participants with ischemic stroke >6 months before and moderate to
severe upper-limb impairment 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
participants were randomized to VNS plus rehabilitation and 11 to
rehabilitation alone. There were no serious adverse
device effects. One patient had transient
vocal cord palsy and dysphagia after implantation. Five had minor
adverse device
effects including nausea 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 chronic stroke will now be performed.
Clinical Trial Registration—URL: https://www.clinicaltrials.gov. Unique identifier: NCT01669161.
No comments:
Post a Comment