Restless Legs Syndrome
Conditions
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.
Interventions
DEVICENoctrix Health NPNS device v1.0 - Active
Wearable device programmed to deliver electrical stimulation to peripheral nerves of the lower limbs.
DEVICENoctrix Health NPNS device v1.0 - Sham
Wearable device programmed to deliver sham stimulation.
Sponsors
Noctrix Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the clinical tolerability, usability, and patient response for the prototype device, with the intention of improving overall device performance. | Weeks 1-2 of each intervention | Subject satisfaction and usability questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score at week 2 | Week 2 of each intervention compared to week prior to study entry | International Restless Legs Syndrome Study Group Rating Scale is a participant-rated questionnaire that rates RLS severity from 0-40, where 40 is the most severe. |
| Change to Summary NRS score of RLS symptom severity | Weeks 1-2 of each intervention | Participant rating of average RLS symptom severity from 0-10 on a Numerical Rating Scale (NRS) scale, where 10 is the most severe. Participants complete a single Summary NRS scale at the end of each 2-week intervention, rating the average RLS symptoms before, during, and after device usage. |
| Change to Daily NRS score of RLS symptom severity | Weeks 1-2 of each intervention | Participant rating of average RLS symptom severity from 0-10 on a Numerical Rating Scale (NRS) scale, where 10 is the most severe. Participants complete the Daily NRS scale each day during each 2-week intervention, rating the RLS symptoms before, during, and after the previous night of device use. |
| Responder rate on CGI-I scale at week 2 relative to baseline | Week 2 of each intervention compared to week prior to study entry | Responder rate is defined as the proportion of responses of Much Improved or Very Much Improved relative to baseline on the 7-point participated-rated Clinical Global Impressions-Improvement (CGI-I) scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change to NRS score of RLS severity during SIT procedure | During the 60 minute SIT procedure | The 60-minute Suggested Immobilization Test (SIT) assesses RLS symptom severity in a controlled procedure in the following three conditions: no device, NPNS device, Sham device. At SIT start and after every 10 minutes, the participant rates average RLS symptom severity from 0-10 on a Numerical Rating Scale (NRS) scale, where 10 is the most severe. |
Countries
United States
Outcome results
None listed