NeuroMetrix, Inc. (NURO),
an innovative health-care company that develops wearable medical
technology and point-of-care tests that help patients and physicians
better manage chronic pain, nerve diseases, and sleep disorders, today
announced preliminary results from a pilot study of its wearable pain
relief technology in subjects with restless leg syndrome (RLS).
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, Massachusetts General Hospital
(a Harvard Medical School teaching hospital).
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 Dr. Winkelman who stated, "Pharmacologic treatments, though
an important advance over the past 20 years for patients with RLS, leave
much to be desired. Effective non-pharmacological treatments would be of
great value, and these are encouraging preliminary results that must now
be confirmed in a sham-controlled study."
"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 Shai N. Gozani,
M.D., Ph.D. President and CEO of NeuroMetrix, Inc. “The next step is to
conduct a formal sham-controlled randomized clinical trial of WINS using
our Quell™ platform in subjects with RLS. We believe that an eventual
RLS indication would substantially expand the market for Quell beyond
chronic pain.”
About NeuroMetrix
NeuroMetrix is an innovative health-care company that develops wearable
medical technology and point-of-care tests that help patients and
physicians better manage chronic pain, nerve diseases, and sleep
disorders. The company is located in Waltham, Massachusetts and was
founded as a spinoff from the Harvard-MIT Division of Health Sciences
and Technology in 1996. For more information, please visit www.NeuroMetrix.com.
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