Medical Device for Restless Legs Syndrome

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Noctrix Health, Inc.

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

No Placebo Group

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.

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.

+3 more

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

+11 more

Trial 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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Investigational Device ProtocolExperimental Treatment1 Intervention

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