NIH-funded research Sbir 2 grant

Closed-loop tonic motor activation therapy for refractory restless legs syndrome

Official title: Developing closed-loop tonic motor activation therapy for treatment of refractory restless legs syndrome

Funded at Noctrix Health, INC · NIH-11330427 · Data updated 2026-11-12

A new, non-invasive treatment called CL-TOMAC would automatically activate therapy during sleep to reduce symptoms for adults with restless legs syndrome and help reduce sleep disruption and dependency on medications.

Quick facts

Grant typeSbir 2 grant
Study typeNIH-funded research
Funding institutionNoctrix Health, INC
NIH-funded
Lab location1 site (Pleasanton, UNITED STATES)
Project startMay 1, 2020
Project endApril 30, 2028
Funding year2026
Award (this year)$1,324,304
NIH project number5R44NS117294-05
Project IDNIH-11330427 on NIH RePORTER

Who could benefit from this research

Could help

Adults 21 years and older with restless legs syndrome who experience sleep disturbance.

Less likely to help

Patients without RLS or those unable to undergo non-invasive nerve stimulation may not benefit.

What this research studies

This project builds a closed-loop version of the Noctrix TOMAC system to detect leg movements during sleep and deliver targeted nerve stimulation automatically. It aims to improve sleep quality by reducing wake after sleep onset and decreasing the need for higher doses of common RLS medications. The study plans to validate the safety and feasibility of the closed-loop system in adults with RLS, using algorithm-driven stimulation during sleep. Through this work, patients may experience better sleep with fewer medication-related side effects.

Why it matters

Potential benefit: If successful, patients may sleep more soundly and rely less on medications for RLS management.

How similar studies have gone: Prior TOMAC approaches showed symptom reduction, and closed-loop approaches are being explored to further optimize outcomes.

Where this research is happening

  • Noctrix Health, INC
    Pleasanton, United States
    Active

Researchers

  • Principal investigator: Charlesworth, Jonathan David — Noctrix Health, INC
  • Study coordinator: Charlesworth, Jonathan David

Related research

Other NIH-funded projects on the same topics.

  • New therapy for treating severe restless legs syndrome

    This study is testing a new therapy called CL-TOMAC that gently stimulates your nerves while you sleep to help manage Restless Legs Syndrome, making it easier for you to get a good night's rest without relying on medications that might have side effects.

    NIH research Noctrix Health, INC · Pleasanton, UNITED STATES · NIH-11064926

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Browse more
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.