Electrical Stimulation via the Scrambler Device as a Treatment for Refractory Restless Legs Syndrome/Willis Ekbom Disease

Study objectives: To evaluate, in a pilot fashion, efficacy and tolerability of electrical counter-stimulation using the Scrambler device in alleviating discomfort and urge to move in patients with medically refractory restless legs syndrome/Willis Ekbom Disease (RLS/WED). Methods: Eligible patients had moderate to very severe RLS/WED symptoms for ≥ 3 months, based on the International Restless Legs Syndrome Study Group (IRLS) Rating Scale. Subjects were treated with Scrambler Therapy for up to ten daily 1-2 hour sessions. Symptoms were monitored using the IRLS as well as questionnaires regarding daily symptoms and global impression of change. Questionnaires were administered at baseline, during therapy, and one-week after the last Scrambler session. Subjects were also queried regarding any adverse effects. Results: Eight subjects were enrolled (M=F). Subjects were on an average of 3 RLS drugs at time of enrollment. Two patients were asked to taper off of gabapentin or pregabalin prior to starting treatments with Scrambler. The IRLS score decreased from a baseline of 27.6 ± 6.2 (mean ± SD) to 19.5 ± 8.0 (p=0.03) following therapy, and to 20.3 ± 10.8 (p=0.07) one week after the last Scrambler treatment. No adverse effects were noted by subjects. Conclusions: Scrambler therapy may be associated with symptom improvements in patients with severe, medically refractory RLS/WED. No adverse effects were associated with therapy. Further work is necessary to characterize this possible treatment option. This study is registered in Clinicaltrials.gov as “Treatment of RLS/WED Symptoms through Sensory Counterstimulation.” ClinicalTrials.gov identifier: NCT03249779.