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NeuroMetrix Touts Positive Pilot Data on Wearable Pain Relief Technology in Restless Leg Syndrome.

M2 PHARMA-August 31, 2015-NeuroMetrix Touts Positive Pilot Data on Wearable Pain Relief Technology in Restless Leg Syndrome


Preliminary results from a pilot study of US-based wearable medical technology and point-of-care test developer NeuroMetrix, Inc.'s wearable pain relief technology in subjects with restless leg syndrome show that the study has met its objective, the company said on Monday.

RLS, which is also known as Willis-Ekbom Disease, is a common sleep disorder characterised 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.

The pilot study was an open-label, single-arm, flexible dosing, four-week trial. The objective of the study was to determine if transcutaneous electrical nerve stimulation, 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.

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 scale, which was statistically significant. Similarly, several sleep related outcomes measures (MOS Sleep Scale) showed statistically significant (or a trend towards) improvement.

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.

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Publication:M2 Pharma
Date:Aug 31, 2015
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