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

20 Participants Needed

Trial Summary

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.

Research Team

Jonathan D Charlesworth, PhD

Principal Investigator

Noctrix Health, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+