Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome
- Conditions
- Restless Legs Syndrome
- Interventions
- Device: Noctrix Health NPNS device v1.0 - ActiveDevice: Noctrix Health NPNS device v1.0 - Sham
- Registration Number
- NCT04700683
- Lead Sponsor
- Noctrix Health, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Noninvasive Peripheral Nerve Stimulation Noctrix Health NPNS device v1.0 - Active NPNS device programmed to deliver active stimulation. Sham control Noctrix Health NPNS device v1.0 - Sham NPNS device programmed to deliver sham stimulation.
- Primary Outcome Measures
Name Time Method Evaluate the clinical tolerability, usability, and patient response for the prototype device, with the intention of improving overall device performance. Weeks 1-2 of each intervention Subject satisfaction and usability questionnaire
- Secondary Outcome Measures
Name Time Method Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score at week 2 Week 2 of each intervention compared to week prior to study entry International Restless Legs Syndrome Study Group Rating Scale is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe.
Change to Summary NRS score of RLS symptom severity Weeks 1-2 of each intervention Participant rating of average RLS symptom severity from 0-10 on a Numerical Rating Scale (NRS) scale, where 10 is the most severe. Participants complete a single Summary NRS scale at the end of each 2-week intervention, rating the average RLS symptoms before, during, and after device usage.
Responder rate on CGI-I scale at week 2 relative to baseline Week 2 of each intervention compared to week prior to study entry Responder rate is defined as the proportion of responses of "Much Improved" or "Very Much Improved" relative to baseline on the 7-point participated-rated Clinical Global Impressions-Improvement (CGI-I) scale.
Change to Daily NRS score of RLS symptom severity Weeks 1-2 of each intervention Participant rating of average RLS symptom severity from 0-10 on a Numerical Rating Scale (NRS) scale, where 10 is the most severe. Participants complete the Daily NRS scale each day during each 2-week intervention, rating the RLS symptoms before, during, and after the previous night of device use.
Trial Locations
- Locations (3)
Mark J Buchfuhrer private practice
🇺🇸Downey, California, United States
SRI International Human Sleep Research Lab
🇺🇸Menlo Park, California, United States
Sleep Medicine Specialists of California
🇺🇸San Ramon, California, United States