Noninvasive neuromodulation reduces symptoms of restless legs syndrome. Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine Buchfuhrer, M. J., Baker, F. C., Singh, H., Kolotovska, V., Adlou, B., Anand, H., de Zambotti, M., Ismail, M., Raghunathan, S., Charlesworth, J. D. 2021


STUDY OBJECTIVES: Restless legs syndrome (RLS) is a common neurological disorder characterized by an uncontrollable nocturnal urge to move the legs and often associated with chronic sleep disturbances. The most common treatments for RLS are medications that can have debilitating side-effects. Here, we evaluated a novel alternative modality of RLS treatment, noninvasive bilateral electrical stimulation of the common peroneal nerve.METHODS: To assess the impact of this noninvasive peripheral nerve stimulation (NPNS) approach on RLS symptomatology, we conducted a multi-site randomized crossover study comparing NPNS to sham. RLS patients with moderate to severe RLS (n=37) self-administered NPNS and sham nightly for 14 days per treatment in randomized order.RESULTS: NPNS resulted in a reduction in RLS severity of 6.81 points on the International RLS Rating Scale (IRLS) relative to 3.38 for sham (p<0.01) and a 66% clinically significant responder rate on the Clinical Global Impressions-Improvement (CGI-I) scale compared to 17% for sham (p<0.01). Subgroup analysis indicated that medication-resistant and medication-naive participants both exhibited similarly robust responses. There were no moderate or serious device-related adverse events.CONCLUSIONS: These results suggest that NPNS could be a promising alternative to pharmacological therapies for RLS and could provide a solution for medication-resistant RLS patients and for medication-naive RLS patients who are unwilling or unable to take medication.CLINICAL TRIAL REGISTRATION: Registry:; Title: Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome; Identifier: NCT04700683; URL:

View details for DOI 10.5664/jcsm.9404

View details for PubMedID 33949942