The U.S. Patent and Trademark Office has issued a patent for Sensory NeuroStimulation’s Relaxis, the only FDA-cleared device for Restless Legs Syndrome (RLS) treatment, the San Clemente, Calif., devicemaker said.
The device uses a pad to provide vibratory counterstimulation for 30 minutes, gradually decreasing in intensity and turning off while the patient is asleep. The treatment is likened to getting a leg massage. Results from two randomized, multi-center, controlled, double-blinded, prospective clinical research studies published in a peer-reviewed journal article indicated that the Relaxis device was found superior to placebo pads for improving sleep quality in patients with primary RLS.
People afflicted with RLS feel uncomfortable, uncontrollable tingling, aching and dysphoria in their legs. RLS episodes typically occur when a person is at rest, about to sleep or sleeping. Sleep interruptions resulting from RLS can reduce quality of life, cause physical fatigue, limit mental functioning and create emotional stress.
Relaxis is available by prescription only. It won U.S. Food and Drug Administration approval last year.According to the federal National Institute of Neurological Disorders and Stroke (NINDS), an estimated 12 million Americans may be suffering from RLS, a life-long neurological condition that causes discomfort, pain and sleep deprivation. RLS symptoms occur primarily while a person is resting, and may increase in severity during the night. Many patients find their only relief comes from physical movement, which causes sleep interruption and subsequently leads to physical fatigue, impaired mental functioning, and emotional stress.
Both adults and children may be affected by RLS, although the condition is twice as prevalent in women. Among the most impacted are people middle-aged or older, as symptoms tend to increase in both frequency and duration with age. In the most severe cases, RLS attacks may occur several times per night, repeatedly causing interrupted sleep and impaired daytime functioning.
To alleviate RLS symptoms, medication therapy is often prescribed, including dopaminergic agents used to treat Parkinson’s disease, anti-convulsants, narcotic opioids, and muscle relaxants and sleep medications such as Benzodiazepines. Unfortunately, some of these medications present the risk of dependence or addiction, and are considered inappropriate for certain RLS sufferers, including pregnant women and dialysis patients. NINDS reports that some drugs also have been found to actually worsen patients’ RLS symptoms over time, despite initially providing relief.