noninvasive peripheral nerve stimulation for restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: prospective multi-site randomized sham-controlled crossover feasibility study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (npns) for patients with moderate-severe primary restless legs syndrome (rls). response to npns investigational device was compared to sham control in a 2x2 crossover design such that subjects were assigned to receive 2 weeks of npns and 2 weeks of sham, in randomized order.


Eligibility criteria:
inclusion criteria: * subject has moderate-severe rls symptoms as defined by a score of 15 or greater points on irls. * rls symptoms are primarily noticeable in the subject's lower legs and/or feet. * subject reports having a medical diagnosis of primary idiopathic restless legs syndrome (rls) or willis-ekbom disorder (wed) or investigator has diagnosed the subject with primary idiopathic restless legs syndrome (rls) or willis-ekbom disorder (wed). * subject has experienced rls symptoms at night on 2 or more nights per week during the previous month. * on typical dose and schedule of rls medication (if any), subject typically experiences rls symptoms on 2 or more nights per week. * rls symptoms are primarily in the evening and night. * subject owns the necessary equipment to respond to texts, phone calls, and video calls. * subject is 18 years of age or older when written informed consent is obtained. * subject has signed a valid, institutional review board (irb)-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in english. exclusion criteria: * subject has rls that is known to be caused by another diagnosed condition. * subject has active implantable medical devices anywhere in the body (including pacemakers), or passive medical devices implanted in the leg. * subject has an uncontrolled sleep disorder other than rls that significantly interferes with their sleep as determined by the trial director or physician. * subject has been diagnosed with one of the following conditions: epilepsy or other seizure disorder, cellulitis or open sores of the legs, renal failure, iron-deficiency anemia, severe movement disorder symptoms (parkinson's disease, huntington's disease, dyskinesia, dystonia), deep vein thrombosis, stage 4-5 chronic kidney disease, multiple sclerosis, current, active or acute or chronic infection other than viral upper respiratory tract infections, a malignancy within the past 5 years (not including basal or squamous cell skin cancer) * subject is on dialysis or anticipated to start dialysis while participating in the study * subject is allergic to electrode gel, polyurethane foam, or lycra. * subject has severe edema in lower legs. * subject has failed a nerve conduction study prescribed by a physician or has been diagnosed with severe peripheral neuropathy. * during visit 1, subject cannot notice the stimulation at the maximal dose or cannot tolerate the stimulation at the minimal effective dose * subject selects statement 2 or is unable to decide which of the following two statements most closely describe their condition: statement 1: my symptoms are best characterized by a strong or overwhelming urge to move my legs. moving my legs often results in temporary relief of that urge. statement 2: my symptoms are best characterized by involuntary leg spasms that happen at regular intervals. these leg spasms can wake me up in the middle of the night." * subject has significantly changed medication dose or schedule of antidepressants, sleep medications, or rls medications within the past 30 days. * recent history of alcohol or recreational drug abuse (within the past 6 months). * subject has received an investigational drug or device within the last 30 days or is planning to receive an investigational device during the duration of the study. * subject has undergone a major surgery (excluding dental work) in the previous 30 days. * subject has another medical condition that may affect validity of the study or put the subject at risk as determined by the investigator. * subject is unable or unwilling to comply with study requirements