# Treatment of Restless Legs Syndrome through non-invasive peripheral nerve stimulation

> **NIH NIH R44** · NOCTRIX HEALTH, INC · 2020 · $461,490

## Abstract

Restless Legs Syndrome (RLS) affects the ability to fall and stay asleep for more than 10% of the western adult
population. In the median age group of 50-79 years alone, more than 25 million adults are seeking treatment for
RLS, making it the second most common sleep disorder in the world. The severe leg sensations of RLS are most
prevalent at night, thus leading to sleep deprivation and its downstream consequences of depressed mood,
irritability, forgetfulness, difficulty learning, and lack of motivation. Voluntary leg movements lead to reduction in
these symptoms; however, such movements are incompatible with sleep. Drug-based RLS therapies are met
with mixed results, becoming progressively less effective over time, and in many cases having debilitating side-
effects. For this reason, a significant portion of RLS patients move to off-label medications, including opiates and
benzodiazepines. There exists a large unmet need for an effective non-drug RLS therapy. The Noctrix Health
wearable Peripheral Nerve Stimulation System (NPNS) is designed to mimic the therapeutic benefits of voluntary
leg movements without the distracting side-effects. Initial open-label studies of acute therapeutic response show
that NPNS reduces RLS symptom severity by 83% in moderate to severe RLS patients. Device development
work is required to translate the NPNS technology into a compact, wearable device that can be reliably self-
administered by patients in the home for daily overnight use. Clinical validation is required to determine
preliminary therapeutic response in key patient sub-populations. This SBIR Fast Track proposal will facilitate
the translation of this promising technology into a wearable, simple-to-use device and evaluate tolerability,
safety, compliance, and response to treatment for candidate clinical sub-populations (drug-naïve, drug-
refractory, and clinician-guided opiate-reduction) through the following Aims: Phase I Aim 1: Design and
validate form factor most compatible for daily overnight use. Design a wearable device that can deliver the
programmed therapy waveform uninterrupted for the requisite duration with a form factor that is minimally
disruptive to sleep from existing company-sourced patient and physician feedback. Aim 2: Integrate
compliance tracking and activity monitoring. Design and integrate 3D motion smart sensing and event
logging into the device. Phase 2 Aim 1: Establish tolerability, compliance, safety, and identify clinical sub-
population therapeutic response. Conduct a clinical trial with 20 patients in each of 3 cohorts (drug-naïve,
drug-refractory, and clinician-guided opiate-reduction) to study tolerability, safety, compliance, and size of
treatment effect. Aim 2: Develop algorithm for detection of RLS-related leg movements. Using the data
provided by on-board sensors (developed in Phase 1 and collected in Phase II Aim 1), develop an algorithm for
detection of RLS-related leg movements during sleep. The algorithm will repo...

## Key facts

- **NIH application ID:** 10010174
- **Project number:** 1R44NS117294-01
- **Recipient organization:** NOCTRIX HEALTH, INC
- **Principal Investigator:** Jonathan David Charlesworth
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $461,490
- **Award type:** 1
- **Project period:** 2020-05-01 → 2021-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010174

## Citation

> US National Institutes of Health, RePORTER application 10010174, Treatment of Restless Legs Syndrome through non-invasive peripheral nerve stimulation (1R44NS117294-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10010174. Licensed CC0.

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