NeuroMetrix announced preliminary results from a pilot study on the safety and efficacy of its Sensus Pain Management System in patients with restless leg syndrome (RLS). The Sensus system contains a transcutaneous electrical nerve stimulator (TENS) unit designed for relief of chronic pain in the lower legs and feet.

The open-label, single-arm, flexible-dosing trial was conducted over 4 weeks to determine the effect of TENS delivered using the Sensus System on sleep in patients with RLS. A total of nine patients were evaluated and two-thirds responded to the treatment based on the Clinical Global Impression of Improvement (CGI-I) scale. RLS severity decreased by 32%, as assessed by the International Restless Leg Syndrome (IRLS) scale and several sleep related outcomes measures (MOS Sleep Scale) showed statistically significant improvement.

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Next steps include a formal sham-controlled randomized clinical trial in subjects with RLS using the company’s Quell platform with wearable intensive nerve stimulation (WINS) technology. The Sensus Pain Management System is available by prescription and is the only TENS unit cleared by the Food and Drug Administration (FDA) for use during sleep.

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