Current Clinical Trials

Posted December 2019

Hormones and Their Role in Restless Legs Syndrome

We need YOUR HELP RLS Community!! We have received funding from the Department of Defense to continue our study of hormones in RLS. This means that we are able to reimburse you for the COST OF YOUR TRAVEL (up to $600) as our research requires a one-time visit to New Haven, Connecticut. Our research aims to uncover the underlying biological mechanisms of RLS. Doing this is essential in order to develop new more effective treatments for RLS and to discover a cure.

Brian Koo, MD and his team at Yale University are conducting research to determine whether levels of specific hormones are increased in the blood and spinal fluid of persons with RLS. The research requires that participants undergo blood draws and a spinal tap.

We are looking for individuals with moderate to severe primary idiopathic RLS who do not have other disorders such as kidney disease, multiple sclerosis, Parkinson disease, or severe neuropathy AND who are not currently taking medicine for RLS. If you are taking medicine for RLS, you can discuss with Dr. Koo about temporarily coming off of your medicine. We know that coming off your medicine, even temporarily, and undergoing a spinal tap are a lot to ask, but this research is important and we need YOUR HELP!!

If you believe you are eligible or have any questions about the research, please contact our study team led by Dr. Brian Koo, MD.

Contact: Your first contact can be via email to Nada Ahmed at nada.ahmed@yale.edu or call (203) 785-7393

Posted September 2019

Investigational Nerve Stimulation Device

We are looking for people with Restless Legs Syndrome (RLS) to test an investigational nerve stimulation device, designed to reduce RLS symptoms. The study is funded by Noctrix Health. You may qualify if you are 18 to 75 years old and have RLS symptoms. If you qualify as a study participant, you will be compensated up to $400 for your participation.

This study involves the evening use of small nerve stimulation devices attached to both legs, actigraphic sleep assessment, and daily electronic surveys for up to 5 weeks at home. In addition, there will be three 2-hr in-lab visits at the Human Sleep Research Laboratory at SRI International in Menlo Park, scheduled in the evening at your convenience. Enrolling in the San Francisco Bay Area Only.

Contact: For more information, please contact the sleep laboratory at 650-859-4532 or sleep@sri.com

Posted July 2019

Clinical Trial for Wearable Compression Vibratory Device—Adults (18 and over)

Are you experiencing bothersome RLS symptoms at least 5 days a week? Have you been experiencing these bothersome symptoms for at least 3 months? Have you been taking the same dosage of medication for RLS or no medication for at least 2 months? If so, you may qualify to participate in a 2-month investigational study to test a wearable compression vibratory device for patients with Restless Legs Syndrome. If you qualify as a study participant, you will receive all study related materials at no cost and be paid for your time upon completion of all study requirements. Enrolling in the San Francisco Bay area only.

If you would like to learn more about this study and to see if you qualify, please contact:

Ryan McCormick at CA Center for Sleep Disorders at 510-263-3331 or rmccormick@sleepdx.com

Posted February 2019

Well-Being and Health in RLS

Restless Legs Syndrome (RLS) is a condition associated with significant lifestyle changes. Researchers at Yale University are conducting a study that looks at health and well-being in patients with RLS. The researchers are looking to study primary RLS, which is RLS that occurs in the absence of diseases like Parkinson’s disease, multiple sclerosis, severe neuropathy, end-stage renal disease, schizophrenia, terminal cancer, and others. The study is a one-time online questionnaire that takes about 10–20 minutes to complete. You will not need to talk to anyone to complete this study, and your response is completely anonymous. There is no way for the researchers or anyone to determine your identity, even after you have completed the questionnaire.

To participate:

  • Follow this link to the survey: https://yalesurvey.ca1.qualtrics.com/jfe/form/SV_4I7rXK9CXrA7wwt
  • The first page contains information about how data is collected and stored. Selecting “I consent to participate in this research study” will initiate the survey.
  • Please read all instructions carefully to ensure that questions are answered appropriately.
  • Most of the questions require a response. Do not skip any sections unless instructed to do so. You will be informed if you accidentally skip a required question.
  • The survey should be completed in one sitting.

Contacts: If you have questions, please contact Nada Ahmed at nada.ahmed@yale.edu

Posted October 2018

RLS & My Teen: What’s Next? — Fight RLS with Science

Is it really tough to get to sleep sometimes? Find out about a study that’s for adolescents dealing with RLS. Sometimes, RLS is often misdiagnosed with a with range of issues, including growing pains or behavioral problems—and that can be tough on everyone around them. Now your child can participate in a study for 13–17-year-olds with RLS. This study is open to those with RLS and living in California, Florida, Illinois, New Jersey, New York, and Texas. Compensation available.

Visit: www.science37.net/rls-teens
Call: (310) 464-2190
Email: RLSstudy@science37.com

Posted March 2016

Does your child have discomfort in their legs that may interfere with their sleep? They may describe their symptoms as throbbing, pulling, creeping, pain or other abnormal sensations felt in the legs when lying down or sitting. Your child may be suffering from adolescent Restless legs Syndrome.

Worldwide Clinical Trials is conducting research studies to test an investigational medication for the treatment of adolescent RLS. You will receive the medication at no charge, an assessment by an RLS expert and compensation for participating in this research clinical trial. The studies will take place at the following locations Amherst (NY), Columbia (SC), Indianapolis (IN), Nashville (TN), Philadelphia (PA), Redwood City (CA), and San Diego (CA). Qualified participants will be compensated for time and travel. To qualify, participants must:

  • be 13-17 years of age
  • be diagnosed with RLS
  • have moderate-to-severe symptoms
  • have parent/legal guardian consent

If you are interested in learning more about this study, or to find out if you qualify call (520)-252-1908 or email Camilla.Alexander@wwctrials.com.

Posted January 2013

If you live in the New York City area, you may be eligible to participate in a new research opportunity.

We are conducting a research study to determine whether there are changes in the retinal structure of the eyes of individuals with Restless Legs Syndrome, also known as Willis-Ekbom Disease (WED/RLS) compared to individuals with Parkinson’s disease, multiple system atrophy, and healthy controls.

The study will take place at the New York University Langone Medical Center and will require one visit, lasting approximately 1-2 hours. The visit will include an initial screening and an eye exam. You will be asked to sit comfortably and to place your chin in a chin rest and to look into a machine that will take pictures of your optic nerve. The eye examination will take approximately 15 minutes and you will not feel anything while the machine takes pictures of your retina (the back of your eye).

There is no direct benefit to you or expense reimbursement available from your participation in the study. It is hoped that the knowledge gained will be of benefit to others in the future. Studies done for this research study are not a part of your regular medical care and will not be included in your medical record.

If interested, please contact Dr. Jose Martinez at Jose.Martinez@nyumc.org.

Further Reading

Clinical Trails: What to Know Before You Go

Inside: Important Information for those considering clinical trail participation

Read More