Vagus Nerve Stimulation + Rehab Feasible After Stroke
No safety concerns raised in randomized pilot study involving 20 patients after ischemic stroke
MONDAY, Dec. 14, 2015 (HealthDay News) -- Vagus nerve stimulation (VNS) paired with rehabilitation appears to be feasible and safe for patients after ischemic stroke, according to a study published online Dec. 8 in Stroke.
Jesse Dawson, M.D., from the University of Glasgow in the United Kingdom, and colleagues conducted a randomized pilot clinical trial involving 20 participants with ischemic stroke more than six months earlier and moderate to severe upper-limb impairment. Participants were randomly allocated to VNS plus rehabilitation (nine participants) or rehabilitation alone (11 patients). Rehabilitation consisted of three two-hour sessions per week for six weeks, each with more than 400 movement trials. Movements were paired with 0.5-second VNS in the VNS group.
The researchers observed no serious adverse effects. After implantation, one patient had transient vocal cord palsy and dysphagia. Minor adverse device effects were seen in five patients, including nausea and taste disturbance on the evening of therapy. The change in Fugl-Meyer Assessment-Upper Extremity score did not differ significantly in the intention-to-treat analysis (between-group difference, 5.7 points; 95 percent confidence interval, −0.4 to 11.8). A significant difference was seen in the change in Fugl-Meyer Assessment-Upper Extremity score in the per-protocol analysis (between-group difference, 6.5 points; 95 percent confidence interval, 0.4 to 12.6).
"This study suggests that VNS paired with rehabilitation is feasible and has not raised safety concerns," the authors write. "Additional studies of VNS in adults with chronic stroke will now be performed."