Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome

Chronic Efficacy and Usability of Transcutaneous Electrical Nerve Stimulation in Subjects With Restless Leg Syndrome (RLS)

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.

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