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New treatment option for Restless Legs Syndrome (RLS)
Official title Optimizing Extended-Duration (XD-) TOMAC Therapy for Restless Legs Syndrome (RLS)
ClinicalTrials.gov ID: NCT07675109
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Subject has signed a valid, IRB-approved informed consent form, can understand the requirements of the study and instructions for device usage, and...
- 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...
- Subject reports that RLS symptoms are most significant in lower legs and/or feet.
- Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study...
You likely can't join if
- The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain...
- 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.
- The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives...
- Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores
See the full eligibility criteria
Who can join
- 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...
- Subject reports that RLS symptoms are most significant in lower legs and/or feet.
- Subject reports that RLS symptoms caused awakenings or interfered with falling back asleep at least 3 nights per week during the month prior to study entry.
- The subject possesses the necessary equipment, internet/phone accessibility, and communication ability to complete electronic questionnaires and respond to electronic communications and phone calls from the research...
- Subject has moderate-severe RLS symptoms as defined by a score of 15 or greater points on IRLS (International Restless Legs Syndrome Study Group Rating Scale).
- Subject is 21 years of age or older.
What rules you out
- 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.
- The subject has a known allergy to device materials, electrode gel, polyurethane foam, or lycra (or a severe previous reaction to medical adhesives or bandages).
- Subject has any of the following at or near the location of device application: Acute injury, Cellulitis, Open sores
- The subject is unable or unwilling to comply with study requirements.
- The subject has a medical condition not listed above that may put them at risk.
- Subject has prior experience with neurostimulation devices developed by the study sponsor
- Subject has a primary sleep disorder other than RLS that significantly interferes with sleep at the present time (e.g. obstructive sleep apnea stably controlled via CPAP would not be an exclusion).
- On nights with no RLS symptoms (if any), subject reports typical sleep onset latency of \>60min.
- Subject has severe peripheral neuropathy affecting the lower legs and/or subject has neuropathy and is unable to clearly distinguish between symptoms of neuropathy and symptoms of RLS.
- Subject reports a habitual sleep schedule that is not primarily aligned with nighttime hours (bedtime 8:00pm-2:00am and morning awakening 4:00am-11:00am), or reports that bedtime regularly varies by more than 4 hours...
- Subject is taking an unstable or inconsistent dose or schedule of medication that is likely to impact RLS symptoms or sleep, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines.
- Subject has changed dose or schedule of medication or treatment that is likely to impact RLS symptoms or sleep in the past 30 days, such as RLS medications, antidepressants, sleep medications, or sedative antihistamines...
- During initial device set-up, device does not properly fit the subject or calibrated intensity settings are outside of operational range
The study team makes the final eligibility decision.
Where it's taking place
- Pleasanton, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pleasanton, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.