Study overview

This study evaluates an investigational treatment option for Restless Legs Syndrome (RLS) based on a wearable device therapy (device that you put on your legs).

The study evaluates investigational prototypes of the Tonic Motor Activation (TOMAC) system. These prototypes have one or more settings or instructions that differ from the commercially available TOMAC System, which is cleared by the FDA and is intended to reduce symptoms of primary moderate-severe Restless Legs Syndrome and to improve sleep quality in adults refractory to medications.

Can I participate?

You may be eligible for this study if:

You have been diagnosed with Restless Legs Syndrome (RLS)

Currently, your RLS symptoms frequently interfere with staying asleep

Common symptoms include discomfort in the legs and feet, urge to move the legs and feet, and difficulty falling and staying asleep

You are willing to maintain your current RLS medication (if any)

*This is not a complete list and other eligibility criteria may apply.

What's involved?

You will test an investigational treatment option for managing the symptoms of RLS based on a wearable study device instead of a medication.

Step 1

Application

Click here to see if you may be eligible for this study.

Step 2

Pre-screening Phone Call

To further evaluate your eligibility and provide additional details about the study, a patient outreach representative may call you.

Step 3

Screening

The study team will determine if you are eligible to participate in the study; if you qualify and decide to participate, you will be enrolled in the study.

Frequently asked questions

How do I get started?

Click “See if you may qualify” and enter your information to express interest in the study.

Why didn’t I qualify?

Studies are designed in specific ways to ensure that the data are meaningful and valid. One or more of the answers that you provided were outside of the guidelines for this study. This does not mean you will not qualify for different research studies.

Is there a chance I will receive a placebo?

No. All participants will receive active study treatment for the full 12-week period.

How do I use the study device?

At the beginning of the study, you will receive training on how to use the study device at home. You will also receive follow-up instructions and training throughout the study.

How does the study device work?

The study device delivers comfortable stimulation to the nerves of the legs. It is worn on both legs just below the knees.

Has the study device been tested before?

Similar versions of TOMAC have been tested in previous clinical studies. Previous studies suggest that similar versions of TOMAC may result in rapid reduction of RLS symptoms, such as reducing discomfort in the legs and feet and reducing the urge to move the legs and feet.

Will I receive compensation?

You will receive compensation for your time and travel.

Can I leave the study at any time?

Yes, you can leave the study at any time.

What is the duration of the study?

The study will last approximately 12 weeks.

What about my current medications?

If you’re currently taking medication, you will be able to continue taking it during the study while using the study device.

Can I keep the study devices after the study is over?

No, you will need to return the study devices after the study.

Are you suffering from Restless Legs Syndrome?

Looking for a potential solution for your RLS?