Electrical contrastimulation on the calf for Restless Legs

Restless Legs Syndrome (RLS) is a sensorimotor disorder characterized by an
irresistible urge to move the legs to stop unpleasant sensations. These
unpleasant sensations are usually experienced in the calves and range in
severity from discomfort to painful. The exact cause of RLS remains unknown and
there is no cure. Treatment is directed at symptom relief only, which can be
achieved with pharmaceuticals or conservatively. Existing pharmacotherapy can
only be administered to target specific patients, is not practical in every RLS
triggering situation, and is not very popular due to the related adverse
effects. Transcutaneous electrical nerve stimulation (TENS) is a safe
non-pharmacological treatment modality for a variety of pain conditions and it
has been shown that TENS can reduce symptoms of RLS. Therefore, to treat RLS
with TENS could offer additional efficacy and improve the therapeutic
repertoire for RLS, with fewer side effects. LEX0 is a novel TENS device
designed to place on the calf, specifically for the treatment of RLS.

Hypothesis: LEX0 reduces symptoms of Restless Legs (RLS).

To assess the efficacy of LEX0 on the calf for Restless Legs (RLS)

Prospective interventional studyl

Subjects are instructed to use LEX0 for 4 weeks in home environment. A user
manual is handed. In the event of an RLS attack, LEX0 is placed with the
electrode patch on the skin of the calf and the preset treatment program of 30
minutes is started. The most affected leg must be treated. There are three
levels of intensity and the most comfortable intensity level below the pain
threshold is chosen. LEX0 does not have to be used with every RLS attack and in
case of a prolonged attack treatment can be continued. Treatment can be stopped
at any time. Before and after each treatment a VAS on RLS symptoms is scored.
During the four-week study subjects keep a diary. Subjects visit the clinic
twice, both times 3 short validated questionnaires about RLS are completed
(IRLS, MOS sleep, RLS-QoL). During the last visit also a questionnaire about
LEX0 usability is taken.

Subject has to visit the clinic two times; at the beginning and end of the
study. During these visits subject completes 3 questionnaires related to RLS.
At the end of the study also a questionnaire about LEX0 usability is taken. The
study duration is 4 weeks in home environment. Subject uses LEX0 as needed and
measures leg discomfort by scoring VAS, before and after treatment. Throughout
the study, subject keeps a diary. There are no risks associated with the
investigational treatment; TENS is an established safe non-pharmacological
treatment modality to use at home for many different pain conditions. There are
no good treatment options for RLS and farmacotherapy has its limitations.
Subject may benefit from this treatment with experiencing symptom relief. By
exception subject may experience a mild skin reaction beneath the stimulation
electrode applied or (muscle)pain or cramps in the calf.