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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noninvasive Peripheral Nerve Stimulation | Active Comparator | NPNS device programmed to deliver active stimulation. |
|
| Sham control | Sham Comparator | NPNS device programmed to deliver sham stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noctrix Health NPNS device v1.0 - Active | Device | Wearable device programmed to deliver electrical stimulation to peripheral nerves of the lower limbs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Weeks 1-2 of each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 2 of each intervention compared to week prior to study entry |
| Measure | Description | Time Frame |
|---|---|---|
| Change to NRS score of RLS severity during 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan D Charlesworth, PhD | Noctrix Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mark J Buchfuhrer private practice | Downey | California | 90241 | United States | ||
| SRI International Human Sleep Research Lab |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36856064 | Derived | 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. | |
| 33949942 | Derived | Buchfuhrer 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 16, 2023 | |
| Reset | Dec 22, 2023 | |
| Release | Sep 13, 2024 | |
| Reset | Nov 20, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 16, 2023 | Dec 22, 2023 | |||
| Sep 13, 2024 |
| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| Noctrix Health NPNS device v1.0 - Sham | Device | Wearable device programmed to deliver sham stimulation. |
|
| 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. |
| 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. | 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. | Week 2 of each intervention compared to week prior to study entry |
| During the 60 minute SIT procedure |
| Menlo Park |
| California |
| 94025 |
| United States |
| Sleep Medicine Specialists of California | San Ramon | California | 94583 | United States |
| Nov 20, 2024 |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |