HOUSTON, Texas — An implanted device that stimulates the vagus nerve has shown promising improvement of arm function in stroke patients in a second small clinical study.
While the primary endpoint — change in functional score after 6 weeks of therapy — was not significantly different between treatment groups, the improvement did appear to become significant after a further 60 days of treatment, as did responder rates.
Lead investigator, Jesse Dawson, MD, University of Glasgow, United Kingdom, reported that the group receiving active stimulation with the device showed a 9-point improvement in upper-limb Fugl-Meyer (UEFM) score at this time point.
“All in all, we feel this is quite promising,” Dr Dawson said. “A 9-point change in this scale is highly likely to be clinically significant.”
This magnitude of change would mean different things for different patients, depending on where they start, he said. “If they start at 20 — which is not much function at all — they might regain some grasp ability so they might be able to carry a plate, for example. If they were in the 30s to start with, they would probably already have the grasp function but they would be able to get back to do more specific tasks.”
The results were presented here at the International Stroke Conference (ISC) 2017.
Commenting on the study, American Heart Association/American Stroke Association spokesperson, Philip Gorelick, MD, MPH, medical director, Hauenstein Neuroscience Center, Grand Rapids, Michigan, described the results as “pretty spectacular.”
“It is always difficult to know what you are getting with these scales, but when you see jumps like this I think it’s safe to conclude that there is clinical significance. There is probably something real going on,” Dr Gorelick said.
“You must remember that these are chronic patients with moderate to severe arm weakness at 18 months down the line from their stroke,” he added. “We think these patients are finished — they are not going to be doing much with that arm. Obviously this study is exploratory, but this raises a lot of hope.”
A larger trial in 120 patients is now planned.