Response to an Investigational Device in Patients With Restless Legs Syndrome

In this 12-week study, participants complete a 2-week baseline (no intervention) followed by 8-weeks of investigational medical device intervention (weeks 3-10) followed by 2-weeks with no intervention (weeks 11-12).

Inclusion criteria

• - 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
• - Subject has received a medical diagnosis of primary restless legs syndrome.
• - 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 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.
• - Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry,
• - Subject reports that RLS symptoms are most significant in lower legs and/or feet.

Exclusion criteria

• - The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).
• - The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
• - The subject has been diagnosed with epilepsy or other seizure disorder.
• - The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.
• - The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages).
• - Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores
• - The subject is unable or unwilling to comply with study requirements.
• - The subject has a medical condition not listed above that may put them at risk.
• - Subject has prior experience with any neurostimulation devices developed by the study sponsor
• - 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).
• - On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of >60min.
• - 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 reports that bedtime is typically outside of 9pm-3am or reports that bedtime regularly varies by more than 4 hours, such as due to shift work.
• - During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range