- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04700683
Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome
January 5, 2021 updated by: Noctrix Health, Inc.
Chronic Efficacy and Usability of Transcutaneous Electrical Nerve Stimulation in Subjects With Restless Leg Syndrome (RLS)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Downey, California, United States, 90241
- Mark J Buchfuhrer private practice
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Menlo Park, California, United States, 94025
- SRI International Human Sleep Research Lab
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San Ramon, California, United States, 94583
- Sleep Medicine Specialists of California
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Noninvasive Peripheral Nerve Stimulation
NPNS device programmed to deliver active stimulation.
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Wearable device programmed to deliver electrical stimulation to peripheral nerves of the lower limbs.
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Sham Comparator: Sham control
NPNS device programmed to deliver sham stimulation.
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Wearable device programmed to deliver sham stimulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the clinical tolerability, usability, and patient response for the prototype device, with the intention of improving overall device performance.
Time Frame: Weeks 1-2 of each intervention
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Subject satisfaction and usability questionnaire
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Weeks 1-2 of each intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score at week 2
Time Frame: Week 2 of each intervention compared to week prior to study entry
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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.
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Week 2 of each intervention compared to week prior to study entry
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Change to Summary NRS score of RLS symptom severity
Time Frame: Weeks 1-2 of each intervention
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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.
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Weeks 1-2 of each intervention
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Change to Daily NRS score of RLS symptom severity
Time Frame: Weeks 1-2 of each intervention
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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.
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Weeks 1-2 of each intervention
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Responder rate on CGI-I scale at week 2 relative to baseline
Time Frame: Week 2 of each intervention compared to week prior to study entry
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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.
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Week 2 of each intervention compared to week prior to study entry
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change to NRS score of RLS severity during SIT procedure
Time Frame: During the 60 minute SIT procedure
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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.
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During the 60 minute SIT procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2019
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
January 4, 2021
First Submitted That Met QC Criteria
January 5, 2021
First Posted (Actual)
January 8, 2021
Study Record Updates
Last Update Posted (Actual)
January 8, 2021
Last Update Submitted That Met QC Criteria
January 5, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RLS-SNS01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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