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RLS, which is also known as Willis-Ekbom Disease, is a common sleep disorder characterized by a strong urge to move the legs at night. It affects up to 14% of the US adult population at varying levels of severity. In addition to its direct impact on sleep, RLS may increase the risk of cardiovascular disease and is associated with an overall higher risk of mortality. It is currently managed using various pharmacological agents, some of which worsen the symptoms over time. Many RLS patients remain under treated.
The pilot study was an open-label, single-arm, flexible dosing, 4-week
trial. The objective of the study was to determine if transcutaneous
electrical nerve stimulation (TENS), when delivered using a wearable
intensive nerve stimulation device (NeuroMetrix SENSUS®), is
an effective and safe treatment for RLS, and to explore its effect on
sleep in subjects with RLS. The principal investigator was John W.
Winkelman MD, PhD, Chief, Sleep Disorders Clinical Research Program,
Departments of Psychiatry and Neurology,
A total of nine subjects were evaluated. Two-thirds of the subjects were
responders to the therapy according to the Clinical Global Impression of
improvement (CGI-I) scale. Overall RLS severity decreased by 32%, as
assessed by the International Restless Leg Syndrome (IRLS) scale, which
was statistically significant. Similarly, several sleep related outcomes
measures (MOS Sleep Scale) showed statistically significant (or a trend
towards) improvement. A complete set of results and analyses will be
published by
"We are encouraged by the results of our wearable intensive nerve
stimulation (WINS) technology in restless leg syndrome. Importantly,
this pilot study represents the first evaluation of wearable
transcutaneous electrical nerve stimulation in RLS and suggests that
WINS may be a viable non-pharmacologic option," said
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