Looking for an alternative treatment to opioid medications for RLS?
You may be eligible to participate in a clinical study to reduce or replace your opioid dosage with a wearable device.
You may be eligible for the RESTFUL study if:
** This is not a complete list and other eligibility criteria may apply
The purpose of this study is to determine if the investigational wearable device therapy can be effective and safe when used as part of a treatment plan with reduced dosage of opioid medications for RLS.
In this 4–6 week clinical trial, you will test a wearable device treatment option for managing the symptoms of RLS.
Click here to see if you may be eligible for this study.
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.
Throughout the 4-6 week study duration, you will:
Opioid medications for RLS, such as methadone, oxycodone (i.e. Percocet®, OxyContin®), buprenorphine (i.e. Suboxone®), or hydrocodone (i.e. Vicodin®) have potential long-term drawbacks such as:
Long term use of opioids can change brain chemistry and lead to drug tolerance, meaning that a higher dose of the opioid is needed to produce the same effect.
Long-term use of opioids causes changes to areas of the brain that control and regulate long-term memory, decision-making, social behaviors and thought processes.
Click “I'm Interested” and enter your information to express interest in the study.
Research studies are designed in specific ways to test the study drug or safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for this trial. This does not mean you will not qualify for different research studies.
No, you will not receive a placebo. All participants will receive active treatment for the entire duration of the study.
There is 1 site in the USA.
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 low-intensity stimulation to the nerves of the legs. It is worn on both legs just below the knees.
The study device has been tested in previous clinical studies. Previous studies suggest that each use of the study device 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 a fixed amount of compensation for your time and travel.
Yes, you can leave the study at any time.
The study will last approximately 4-6 weeks
• You will take a lower dosage of your opioid RLS medications throughout the study.
• If you’re currently taking other medication(s), you will be able to continue taking them during the study
No, you will need to return the study devices after the study.