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.

LEX0 reduces symptoms of Restless Legs.

Before and after each treatment with LEX0: VAS
Visit 1 (begin study) : IRLS, MOS-sleep, RLS-QoL
Visit 2 (end study) : IRLS, MOS-sleep, RLS-QoL

Subjects are instructed to use LEX0 for 4 weeks in home environment for their restless legs, as needed. An 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. There are three levels of intensity and the most comfortable intensity level below painful threshold must be chosen. Subjects can stop treatment any time. In case of a prolonged attack treatment can be continued. Before and after each treatment session a VAS on RLS symptoms is scored. During the four-week study subjects keep a diary. Subjects have to visit the clinic at the begin and end of the study, and fill in questionnaires related to RLS and LEX0 usability.