Noninvasive Peripheral Nerve Stimulation for Medication-Naive and Medication-Refractory RLS

Completed · Not applicable · Has a placebo group

Conditions studied: Restless Legs Syndrome

In brief

Prospective multi-site randomized sham-controlled study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs Syndrome (RLS) who are either medication-naive or medication-refractory.

Key facts

Study ID

NCT05214963

Run by

Noctrix Health, Inc.

People needed

58

Starts

2022-03-08

Expected to finish

2023-10-24

Last updated by the study team

2023-12-15

Who can join

Age: 22 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has received a medical diagnosis of primary restless legs syndrome (RLS).
• Subject is either medication-naïve or medication-refractory.
• Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale) over the week prior to study entry.
• RLS symptoms interfered with sleep on at least 3 nights per week during the month prior to study entry.
• RLS symptoms are most significant in the subject's lower legs and/or feet.
• RLS symptoms are most significant after 6pm.
• Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines.
• Subject agrees to not make major lifestyle changes during the study that would significantly affect bedtime, such as major changes to diet, exercise, or career.
• Subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research staff throughout the in-home portion of the study.
• Subject is ≥ 22 and ≤ 89 years of age when written informed consent is obtained.
• Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English.

You may not qualify if…

• Subject has RLS that is known to be caused by another diagnosed condition (i.e. secondary RLS).
• Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms, such as antidepressants, sleep medications, or sedative antihistamines or has changed dosage within the past 30 days.
• Subject has changed dose and schedule of RLS medications within the month prior to study entry or is otherwise on an inconsistent dose or schedule of RLS medications.
• Subject has prior experience with Noctrix Health NPNS devices.
• Subject was misdiagnosed with RLS, as determined by the investigator (e.g. actual diagnosis of PLMD, arthritis, leg spasms or neuropathy without comorbid RLS).
• Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion).
• Subject has active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators) or metal implant at the site of study device electrode application.
• Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
• Subject has been diagnosed with one of the following conditions:
• Epilepsy or other seizure disorder
• Current, active or acute or chronic infection other than common cold
• A malignancy within the past 5 years (not including basal or squamous cell skin cancer)
• Stage 4-5 chronic kidney disease or renal failure
• Severe movement disorder symptoms (Parkinson's disease, Huntington's disease, dyskinesia, dystonia)
• Deep vein thrombosis
• Multiple sclerosis
• Subject has moderate or severe cognitive disorder or mental illness.
• Subject has current diagnosis of iron-deficient anemia or history of iron-deficient anemia within the past year.
• Subject has known allergy to device materials or severe previous reaction to medical adhesives or bandages.
• Subject has severe edema affecting lower legs.
• Subject has any of the following at or near the location of device application.
• Acute injury
• Cellulitis
• Open sores
• Other skin condition

Where it is running

• SRI International Human Sleep Research Lab — Menlo Park, California, United States
• Sleep Medicine Specialists of California — San Ramon, California, United States
• Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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