Is Restless Legs Syndrome disrupting your sleep?
You may be eligible to participate in a study evaluating a wearable device for RLS symptoms.
This study is currently paused. Please email clinical@noctrixhealth.com for more information.
You may be eligible to participate in a study evaluating a wearable device for RLS symptoms.
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.
You may be eligible for this study if:
*This is not a complete list and other eligibility criteria may apply.
The purpose of this study is to gain insights into ways to further improve the TOMAC system for individuals with RLS, including improving its effects on reducing RLS symptoms and improving sleep quality.
In this 12-week study, you will test an investigational treatment option for managing the symptoms of RLS based on a wearable study device instead of a medication.
If you may be eligible, a patient outreach representative will call you, provide additional details about the study, and further evaluate your eligibility.
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.
During the 12-week study duration, you will:
The investigational device in this study is based on a wearable medical study device instead of a pill. The study device is worn on both legs, just below your knees.
Previous studies suggest that each use of the study device may result in rapid reduction of RLS symptoms, reducing discomfort in the legs and feet and reducing the urge to move the legs and feet.
Click “See if you may qualify” and enter your information to express interest in the study.
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.
No. All participants will receive active study treatment for the full 12-week period.
The study is being conducted at one site in Pleasanton, California.
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.
The study device delivers comfortable stimulation to the nerves of the legs. It is worn on both legs just below the knees.
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.
You will receive compensation for your time and travel.
Yes, you can leave the study at any time.
The study will last approximately 12 weeks.
If you’re currently taking medication, you will be able to continue taking it during the study while using the study device.
No, you will need to return the study devices after the study.
