Medical Device for Restless Legs Syndrome

Overseen By Jonathan D Charlesworth, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Noctrix Health, Inc.

Disqualifiers: Active medical device, Epilepsy, Cognitive disorder, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new noninvasive device to assess its effects on restless legs syndrome (RLS) symptoms. Researchers aim to determine if the device is safe, easy to use, and effective in reducing the discomfort that disrupts sleep. Individuals diagnosed with moderate to severe RLS, experiencing symptoms in their lower legs or feet, might be suitable candidates. Participants will use the device for eight weeks, must follow simple instructions, and should not alter their current RLS treatments during the trial. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance RLS treatment options.

Will I have to stop taking my current medications?

You won't have to stop taking your current medications, but you must not change the dosage or schedule of any medications that affect restless legs syndrome symptoms during the study.

What prior data suggests that this device is safe for treating restless legs syndrome?

Research shows that noninvasive devices, like the one being tested for restless legs syndrome (RLS), are generally safe. Experts consider this device low risk. Studies indicate that these devices are usually safe and well-tolerated by patients.

In other research, similar devices have been used without causing serious side effects. These studies also demonstrate their effectiveness in reducing RLS symptoms, supporting their safety. While this specific device remains under study, past research suggests it should be safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this investigational noninvasive neuromodulation device for Restless Legs Syndrome because it offers a different approach from traditional treatments like medications or lifestyle changes. Unlike typical options that often involve oral drugs to manage symptoms, this device uses a noninvasive method to target the nerves directly, potentially reducing discomfort without the side effects associated with medication. Additionally, the device's unique delivery method may offer a more convenient and user-friendly experience, making it an attractive alternative for those seeking relief from persistent symptoms.

What evidence suggests that this device is effective for restless legs syndrome?

Research has shown that noninvasive neuromodulation can effectively reduce symptoms of restless legs syndrome (RLS). This technique gently stimulates nerves in the legs to help calm them. Studies have demonstrated that similar methods, like TOMAC, not only lessen RLS symptoms but are also safe for both new patients and those who haven't found relief with other treatments. Specifically, one study found that activating certain pathways in the legs provides lasting relief from RLS symptoms. These findings suggest that the investigational noninvasive neuromodulation device, which participants in this trial will use, might be a promising way to manage RLS symptoms effectively. ^{1 2 3 5 6}

Who Is on the Research Team?

Jonathan D Charlesworth, PhD

Principal Investigator

Noctrix Health, Inc.

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with a medical diagnosis of primary restless legs syndrome (RLS) who have moderate to severe symptoms. Participants must not change their RLS medication during the study and should experience sleep disturbances due to RLS at least three nights per week. Exclusions include allergies to device materials, active medical implants, prior use of sponsor's neurostimulation devices, irregular bedtimes, epilepsy, metal implants at electrode sites, severe cognitive disorders or mental illness.

Inclusion Criteria

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

I have been diagnosed with primary restless legs syndrome.

I agree not to change my medication doses for RLS or related symptoms during the study.

Exclusion Criteria

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)

The subject has an active medical device implant anywhere in the body (including but not limited to pacemakers, spinal cord stimulators, deep brain stimulators)

Subject has prior experience with any neurostimulation devices developed by the study sponsor

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete a 2-week baseline with no intervention

2 weeks

1 visit (in-person)

Treatment

Participants use the investigational noninvasive neuromodulation device

8 weeks

Weekly check-ins (virtual)

Post-Treatment Observation

Participants undergo a 2-week period with no intervention to observe any changes post-treatment

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Investigational Noninvasive Neuromodulation Device

Trial Overview The trial is testing a new noninvasive neuromodulation device designed for patients with restless legs syndrome. The study will evaluate how safe it is and how well it works in reducing RLS symptoms. The investigational device has been deemed low-risk by an IRB.

How Is the Trial Designed?

Group I: Investigational Device Protocol Experimental Treatment 1 Intervention

Participants will use the investigational noninvasive neuromodulation device as instructed over a period of 8 weeks (weeks 3 through 10).

Who Is Running the Clinical Trial?

Noctrix Health, Inc.

Lead Sponsor

Trials

7

Recruited

700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8656897/

Noninvasive neuromodulation reduces symptoms of restless ... We evaluated a novel alternative modality of RLS treatment, noninvasive bilateral electrical stimulation of the common peroneal nerve.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06866132

NCT06866132 | Response to an Investigational Device in ... This study assesses the tolerability, safety, and impact of an investigational medical device on restless legs syndrome symptoms.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1389945724003885

Efficacy and safety of TOMAC for treatment of medication- ... TOMAC reduces restless legs syndrome (RLS) symptoms. TOMAC is efficacious for both medication-refractory and -naïve RLS patients. TOMAC is safe and well ...

4. academic.oup.com academic.oup.com/sleep/article/46/10/zsad188/7223621

Long-term efficacy and safety of tonic motor activation for ... This paper presents results from an extension study showing that longer-duration TOMAC treatment over 28–32 weeks provides robust and durable benefits at very ...

5. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10536

Bilateral high-frequency noninvasive peroneal nerve ... These results demonstrate that NPNS reduces RLS symptoms by activating afferent pathways, thereby generating tonic and sustained leg muscle activity without ...

6. academic.oup.com academic.oup.com/sleep/article/46/10/zsad190/7225271

Efficacy and safety of tonic motor activation (TOMAC) for ... TOMAC was safe, well tolerated, and reduced symptoms of RLS in medication-refractory patients. TOMAC is a promising new treatment for this population.