Status:
COMPLETED
Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome
Lead Sponsor:
Noctrix Health, Inc.
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04700683
Start Date
July 14 2019
End Date
March 1 2020
Last Update
January 8 2021
Active Locations (3)
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1
Mark J Buchfuhrer private practice
Downey, California, United States, 90241
2
SRI International Human Sleep Research Lab
Menlo Park, California, United States, 94025
3
Sleep Medicine Specialists of California
San Ramon, California, United States, 94583