New device offers Drug-Free hope for restless legs sufferers
NCT ID NCT06076499
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is checking the long-term safety and effectiveness of a device called the Noctrix TOMAC System for people with restless legs syndrome. The device uses mild nerve stimulation to calm leg discomfort. Researchers are following 325 patients for one year to see if symptoms improve and if any side effects appear. It's an observational study, meaning participants use the device as part of their normal care, and no new treatment is being tested.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
NTX100 TOMAC System (non-invasive nerve stimulation device)
What this could lead to
If successful, this could confirm the TOMAC device as a safe, long-term option to ease restless legs symptoms without medication.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. The device may not work for everyone, and long-term side effects are still being tracked.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Pain in Restless Legs Syndrome Study | NCT07679087
- Epidural Injection for Restless Legs in Spinal S NCT07637643
- Botulinum Toxin for Restless Legs Syndrome – NCT00949806
- Ecopipam for RLS Augmentation – NCT03218969
- Dry Needling for Restless Legs Syndrome | NCT05860751
- d-Methadone for Restless Legs Syndrome – NCT04145674
Contacts and locations
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Locations
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Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201, United States
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Clayton Sleep Institute
St Louis, Missouri, 63123, United States
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Mark J Buchfuhrer, MD Office
Downey, California, 90241, United States
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Neurocare, Inc.
Newton, Massachusetts, 02459, United States
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Ohio Sleep Medicine and Institute
Dublin, Ohio, 43017, United States
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Sleep Medicine Specialists of California
San Ramon, California, 94583, United States
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States