Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS)
ConditionRestless Legs Syndrome (RLS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorNoctrix Health, Inc.
About 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.
Eligibility criteria
Qualifiers
Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and can converse in English
Subject has received a medical diagnosis of primary restless legs syndrome (RLS).
Subject agrees to not change dosage or schedule of any medications that are known to impact RLS symptoms during the study, including RLS medications, antidepressants, sleep medications, or sedative antihistamines or treatments such as CPAP (continuous positive airway pressure).
Subject reports that RLS symptoms are most significant in lower legs and/or feet.
Disqualifiers
The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators).
The subject has a metal implant at the site of the study device electrode application (not including knee replacements).
The subject has been diagnosed with epilepsy or other seizure disorder.
The subject has a moderate or severe cognitive disorder or mental illness that would affect his or her ability to participate in the study.
Trial design
Treatments tested in this trial
- Investigational Extended Duration (XD-) TOMAC Therapy
- Tonic Motor Activation (TOMAC) Therapy
Treatment groups
20 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov