Medical Device Alternatives to RLS Drugs

Fred Burbank, M.D. and Cheryl Segawa, M.S.

Restless Legs Syndrome (RLS) is a common neurological disorder, affecting 2.5-15% of the general Western population. For one-third to one-half of RLS suffers, daily function is impaired due to sleep loss. RLS patients dread the onset of each RLS attack because attacks are so uncomfortable. Drugs that cross the blood-brain barrier are currently the most widely accepted treatment for RLS. In the 1980s ergot and non-ergot derived dopaminergic drugs were proposed as treatments of RLS. During the five year period between 2005-2009 publications on PubMed containing the words “restless legs” and “dopamine” reached a peak of 334 articles. However, like the appearance of articles describing tardive dyskinesia following widespread use of anti-psychotic drugs in 1970s, reports began surfacing of worrisome mid- and longer-term complication following dopaminergic drug treatment of RLS.

The most common dopaminergic drug side effect is referred to as “augmentation,” a mild-sounding word for a very troublesome phenomenon: worsening of RLS severity during the course of treatment. Worsening includes greater RLS severity than before the start of drug therapy, expansion of RLS dysphoria from the legs to the arms, and the experience of RLS symptoms earlier and earlier in the day. Concern about augmentation is now so high that a half-day, postgraduate course devoted to mitigating augmentation was presented at the 2016 SLEEP meeting in Denver, CO.

Because initial dopaminergic drug treatment of RLS seemed so promising, medical device treatments of RLS have at times been dismissed out-of-hand. Because devices have no long-term, drug-like side effects, they need to be evaluated soberly.

We provide a limited review of all known medical devices that have been proposed for RLS treatment and have some form of published data. A more detailed description of the Relaxis (Sensory NeuroStimulation, Inc., San Clemente, CA, USA) counterstimulation system is provided as it is the only Class II, prescription device that has been evaluated and cleared by the United States Food and Drug Administration (FDA) for treating sleep disturbance in RLS patients.

TO READ THE FULL LENGTH ARTICLE, PLEASE CLICK ON THIS LINK:

Medical Device Alternatives to RLS Drugs – Fred Burbank, M.D. and Cheryl Segawa, M.S.

TO READ THE FULL LENGTH ARTICLE, PLEASE CLICK ON THIS LINK:

Medical Device Alternatives to RLS Drugs – Fred Burbank, M.D. and Cheryl Segawa, M.S.

TO VIEW THE TABLE OF CONTENTS, PLEASE CLICK ON THE IMAGE BELOW:

Table of Contents - Medical Device Alternatives to RLS Drugs - Fred Burbank, M.D. and Cheryl Segawa, M.S.