Extended-Duration TOMAC Therapy for Restless Legs Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This study assesses the tolerability, safety, and impact of an investigational medical device on restless legs syndrome symptoms.
The IRB has established that the investigational device is non-significant risk.
Who Is on the Research Team?
Jonathan D Charlesworth, PhD
Principal Investigator
Noctrix Health
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with restless legs syndrome (RLS) who are interested in trying a new medical device therapy. Specific inclusion and exclusion criteria are not detailed, but participants should have RLS and be able to use the study device.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Investigational Extended Duration (XD-) TOMAC Therapy
- Tonic Motor Activation (TOMAC) Therapy
Trial Overview
The study is testing an investigational extended-duration TOMAC therapy, which uses a medical device designed to help relieve symptoms of restless legs syndrome. The safety, tolerability, and effects on symptoms will be evaluated.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will use investigational noninvasive neuromodulation device for XD-TOMAC therapy as instructed for 3, 2-week periods over the final 6-weeks of the study. The XD-TOMAC therapy settings may change for each of the 2-week periods in a pseudo-randomized order. Investigational XD-TOMAC settings may include different methods for modulating the stimulation waveform.
Participants will use investigational noninvasive neuromodulation device for XD-TOMAC therapy as instructed for 3, 2-week periods over the final 6-weeks of the study. The XD-TOMAC therapy settings may change for each of the 2-week periods in a pseudo-randomized order. Investigational XD-TOMAC settings may include different methods for modulating the stimulation waveform.
Participants will use investigational noninvasive neuromodulation device for XD-TOMAC therapy as instructed for 3, 2-week periods over the final 6-weeks of the study. The XD-TOMAC therapy settings may change for each of the 2-week periods in a pseudo-randomized order. Investigational XD-TOMAC settings may include different methods for modulating the stimulation waveform.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Noctrix Health, Inc.
Lead Sponsor
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