Restless Legs SyndromeNCT04700683
Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome
A study testing Noctrix Health NPNS device v1.0 - Active in people with Restless Legs Syndrome, run by Noctrix Health, Inc. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- What is being tested?
- Noctrix Health NPNS device v1.0 - Active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jul 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mark J Buchfuhrer private practice
Downey, California, 90241
SRI International Human Sleep Research Lab
Menlo Park, California, 94025
Sleep Medicine Specialists of California
San Ramon, California, 94583
About this study
Official title: 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.
- Conditions
- Restless Legs Syndrome
- Being tested
- Noctrix Health NPNS device v1.0 - Active, Noctrix Health NPNS device v1.0 - Sham
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noctrix Health NPNS device v1.0 - ActiveDevice
Wearable device programmed to deliver electrical stimulation to peripheral nerves of the lower limbs.
Noctrix Health NPNS device v1.0 - ShamDevice
Wearable device programmed to deliver sham stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Peripheral Nerve Stimulation | Active comparator | NPNS device programmed to deliver active stimulation. Receives: Device: Noctrix Health NPNS device v1.0 - Active |
| Sham control | Sham comparator | NPNS device programmed to deliver sham stimulation. Receives: Device: Noctrix Health NPNS device v1.0 - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical tolerability, usability, and patient response for the prototype device, with the intention of improving overall device performance.
Subject satisfaction and usability questionnaire
Measured: Weeks 1-2 of each intervention
Secondary outcomes (4)
Change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) score at week 2
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.
Measured: Week 2 of each intervention compared to week prior to study entry
Change to Summary NRS score of RLS symptom severity
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.
Measured: Weeks 1-2 of each intervention
Change to Daily NRS score of RLS symptom severity
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.
Measured: Weeks 1-2 of each intervention
Responder rate on CGI-I scale at week 2 relative to baseline
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.
Measured: Week 2 of each intervention compared to week prior to study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start14 Jul 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noctrix Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan D Charlesworth, PhD, Study director, Noctrix Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700683
- Sponsor's protocol ID
- RLS-SNS01
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Charlesworth JD, Adlou B, Singh H, Buchfuhrer MJ. Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms. J Clin Sleep Med. 2023 Jul 1;19(7):1199-1209. doi: 10.5664/jcsm.10536.
PubMed 36856064Buchfuhrer MJ, Baker FC, Singh H, Kolotovska V, Adlou B, Anand H, de Zambotti M, Ismail M, Raghunathan S, Charlesworth JD. Noninvasive neuromodulation reduces symptoms of restless legs syndrome. J Clin Sleep Med. 2021 Aug 1;17(8):1685-1694. doi: 10.5664/jcsm.9404.
PubMed 33949942
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Efficacy and Usability of Transcutaneous Electrical Nerve Stimulation in Subjects With Restless Leg Syndrome (RLS)
- ClinicalTrials.gov ID
- NCT04700683
- Acronym / sponsor ID
- RLS-SNS01
- Conditions
- Restless Legs Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Noctrix Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Peripheral Nerve Stimulation | Active comparator | Device: Noctrix Health NPNS device v1.0 - ActiveNPNS device programmed to deliver active stimulation. |
| Sham control | Sham comparator | Device: Noctrix Health NPNS device v1.0 - ShamNPNS device programmed to deliver sham stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noctrix Health NPNS device v1.0 - ActiveWearable device programmed to deliver electrical stimulation to peripheral nerves of the lower limbs. | Device | Noninvasive Peripheral Nerve Stimulation |
| Noctrix Health NPNS device v1.0 - ShamWearable device programmed to deliver sham stimulation. | Device | Sham control |
Primary outcome
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
Subject satisfaction and usability questionnaire
4 secondary outcomes
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
Change to Summary NRS score of RLS symptom severity
Time frame: Weeks 1-2 of each intervention
Change to Daily NRS score of RLS symptom severity
Time frame: Weeks 1-2 of each intervention
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Derived from this study: PubMed 36856064Charlesworth JD, Adlou B, Singh H, Buchfuhrer MJ. Bilateral high-frequency noninvasive peroneal nerve stimulation evokes tonic leg muscle activation for sleep-compatible reduction of restless legs syndrome symptoms. J Clin Sleep Med. 2023 Jul 1;19(7):1199-1209. doi: 10.5664/jcsm.10536.
- Derived from this study: PubMed 33949942Buchfuhrer MJ, Baker FC, Singh H, Kolotovska V, Adlou B, Anand H, de Zambotti M, Ismail M, Raghunathan S, Charlesworth JD. Noninvasive neuromodulation reduces symptoms of restless legs syndrome. J Clin Sleep Med. 2021 Aug 1;17(8):1685-1694. doi: 10.5664/jcsm.9404.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan D Charlesworth, PhD study director
Noctrix Health, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noctrix Health NPNS device v1.0 - Active in people with Restless Legs Syndrome, run by Noctrix Health, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700683, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021; AzTrials last refreshed its copy on 1 Nov 2026.