Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome

Noctrix Health

Status

Completed

Conditions

Restless Legs Syndrome

Treatments

Device: Noctrix Health NPNS device v1.0 - Active

Device: Noctrix Health NPNS device v1.0 - Sham

Study type

Interventional

Funder types

Industry

Identifiers

NCT04700683

RLS-SNS01

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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