Clinical trial NCT04700683: Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome
Official title: Chronic Efficacy and Usability of Transcutaneous Electrical Nerve Stimulation in Subjects With Restless Leg Syndrome (RLS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Restless Legs Syndrome
Lead sponsor: Noctrix Health, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Evaluate the clinical tolerability, usability, and patient response for the prototype device, with the intention of improving overall device performance.
timeFrame: Weeks 1-2 of each intervention
Secondary outcomes:
measure: Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score at week 2
timeFrame: Week 2 of each intervention compared to week prior to study entry
measure: Change to Summary NRS score of RLS symptom severity
timeFrame: Weeks 1-2 of each intervention
measure: Change to Daily NRS score of RLS symptom severity
timeFrame: Weeks 1-2 of each intervention
measure: Responder rate on CGI-I scale at week 2 relative to baseline
timeFrame: Week 2 of each intervention compared to week prior to study entry
Other outcomes:
measure: Change to NRS score of RLS severity during SIT procedure
timeFrame: During the 60 minute SIT procedure
Locations:
city: Downey
country: United States
facility: Mark J Buchfuhrer private practice
state: California
city: Menlo Park
country: United States
facility: SRI International Human Sleep Research Lab
state: California
city: San Ramon
country: United States
facility: Sleep Medicine Specialists of California
state: California
Study officials:
affiliation: Noctrix Health, Inc.
name: Jonathan D Charlesworth, PhD
role: STUDY_DIRECTOR
References:
citation: Buchfuhrer MJ, Baker FC, Singh H, Kolotovska V, Adlou B, Anand H, de Zambotti M, Ismail M, Raghunathan S, Charlesworth JD. Noninvasive neuromodulation reduces symptoms of restless legs syndrome. J Clin Sleep Med. 2021 Aug 1;17(8):1685-1694. doi: 10.5664/jcsm.9404.