Restless Legs Syndrome Foundation Blog

Study: Hemoglobin Levels, Not Serum Ferritin, May Indicate a Better Response to Iron Intervention

Iron is fundamental to the healthy functioning of the body’s organs, including the brain. Its connection to the production of red blood cells is also a major determining factor in clinical practice when prescribing iron intervention. However, according to some scientists, the guidelines for iron replacement in neurological disorders, such as restless leg syndrome (RLS), are poorly defined.

“The current thinking, although not supported by all RLS physicians, is that serum ferritin levels are a measure of iron status and serve as a guidepost for iron replacement therapy," said RLS Foundation Scientific and Medical Advisory Board Member, Dr. James R. Connor. However, new research conducted by Connor and his team, and published in Fluids Barriers CNS, suggests that a patient’s hemoglobin levels may be a better indicator in determining the treatment guidelines for iron therapy.

The researchers conducted a preliminary research study to determine if the body’s iron status is communicated to the brain and they were able to show that iron transport does relate positively with hemoglobin (iron level measurement in the blood), but not with serum ferritin levels.

The team created a model to test their hypothesis. Using a cell culture model to mimic the blood vessels in the brain, they placed transferrin complexed with iron on one side of the cells (representing the blood side) and they put human cerebrospinal fluid on the other side of the cells which represented the brain side. The cerebrospinal fluid was randomly selected from more than 350 individuals enrolled in a study at Emory University for symptoms of excessive daytime sleepiness or other neurological disorders of excessive daytime sleepiness such as narcolepsy. Four additional samples came from an RLS study at Johns Hopkins University. Study samples were derived solely from females of northern European ancestry between the ages of 35 to 66 who were not considered anemic, a condition lacking healthy red blood cells.

The scientists said according to their findings, "the demand for iron for the production of blood cells in the bone marrow outweighs brain iron requirements. Thus, the study is showing that serum ferritin level, which is the traditional metric that is thought to reflect total body iron stores and relied upon to inform treatment decisions, may not be the preferred lab test when attempting to promote brain iron uptake.”

Connor said the data suggests that the hemoglobin levels may be a better indicator of which patients will respond to iron intervention and explains some of the individual differences in responders. "The data in this study supports physicians who consider serum ferritin levels an insufficient measure to determine which patients will respond to iron interventions. The next step would be to evaluate how hemoglobin levels impact response to iron treatment in RLS in a large population study."

About the Survey

Why should I take the RLS Patient Odyssey Survey II? – Data collected in the Patient Odyssey Survey II will offer researchers information on the long-term burden of disease, leading to improved medical treatments and improved quality of life. Your input matters! “This study will provide data to accelerate and focus our efforts to address these challenges and improve quality of life for RLS patients and their families.” -Karla Dzienkowski, Executive Director, RLS Foundation.

Who can take the survey? – The Patient Odyssey Survey II is open to anyone with RLS worldwide, with a separate survey open to partners or caregivers living in the same household.

Where can I find the survey links? – The patient and partner survey can be found on our website at: www.rls.org/odyssey. Or you can access the surveys directly on the survey platform website (see below).

How long will it take to complete? – The patient survey should take approximately 60 minutes to complete, and the partner/companion survey will take about 20 minutes to complete. However, you do NOT have to complete the survey in one sitting; the deadline to submit responses is Friday, October 23, at midnight.

Can I request a paper copy? – Absolutely! Contact us, and we can send you a printed survey with a return envelope. We can only mail to US addresses. Email maddie@rls.org to request a copy and be sure to include your name and mailing address. Be sure to mail your survey back to us by Friday, October 23.

How will the results be shared? – Results will be shared with the RLS community and the public in 2021, prepared for publication in the medical literature and presented in scientific meetings. Findings will also be shared with health policymakers through the RLS Foundation's Advocacy Initiative. It is important to note that protecting your privacy is of utmost importance to us.

Will my responses be confidential? – Your responses will remain confidential and anonymous. No individual identifying information is requested of or collected from survey participants.

Completing the Survey

What if I need a break while I’m taking the survey? Can I save my work and come back to it? – No problem! We recognize that the survey is long. The questions are designed to cover all aspects of living with RLS. You do NOT have to complete the survey in one sitting; you can close your browser and return using the same device to www.rls.org/odyssey to pick back up exactly where you left off. Just be sure to complete and submit the survey by midnight on Friday, October 23!

What do I need to do to make sure I submit the complete survey correctly? – After the final survey question you will be routed to an exit page thanking you for your participation. To ensure that your responses are recorded, make sure you click DONE at the bottom of this page; you will receive a “Success Page” to confirm that your responses have been received.

What if I don’t want to answer a question? – We understand that some questions may be difficult or uncomfortable to answer. You may choose to leave any questions blank you don’t wish to answer.

Is there a way to make the survey font size larger? – To zoom in on your computer screen, press the "Control +" keys on your keyboard (or "Command +" if you are using a Mac). You can also try adjusting the brightness of your computer and/or iPad screen. If you would prefer, we can mail a printed survey to your US address with a return envelope. Email maddie@rls.org to request a copy and be sure to include your name and mailing address.

What if I don’t find the right answer for me in the list of options for a multiple-choice question? – The RLS Patient Odyssey Survey II was written by medical professionals on our Scientific & Medical Advisory Board and includes questions from existing RLS validated questionnaires. One of the requirements when using validated questionnaires is that the questions must be presented exactly as written, with no changes to the original questionnaire. Just try to answer the question to the best of your ability, i.e., what is most reflective or representative of your RLS experience.

How do I enter dosages (invalid answer)? – Questions that ask for dosages require a numerical value only. Do not use letters (such as mg for milligrams). If you are instructed to take your medication several times per day, please provide the total dosage. For example, if your prescription states: gabapentin 600 mg TID PO, which translates to 600 mg three times daily per mouth, you would enter the number 1800. If a medication is used across multiple days, you can provide an average. If you are unsure you may email maddie@rls.org for assistance.

What should I do if I encounter technical difficulties? – Unfortunately, technical difficulties do happen. If this happens to you, you can contact us for a printed survey (see above), or take the survey directly on the Survey Monkey website (the survey development platform) here:

Who can I contact with questions? – For all other questions, comments and concerns, please email maddie@rls.org or call (512) 366-9109. Your input is very valuable to us!

East Carolina University associate professor receives patent for treating Restless Legs Syndrome

An East Carolina University faculty member’s latest patent may change the way Restless Legs Syndrome (RLS) is treated, leading to more effective care over a longer period of time for patients.

Stefan Clemens, an associate professor in the Brody School of Medicine’s Department of Physiology, was awarded U.S. Patent 10,751,327 on Aug. 25 for his novel treatment method for the treatment of RLS.

Restless Legs Syndrome is a nervous system disorder that affects between 5% and 8% of the population in the United States. Those suffering from RLS experience an uncontrollable urge to move their legs caused by an unpleasant sensation. While the exact cause of RLS is still unknown, the syndrome is typically treated with dopaminergic drugs — medications that replace or prevent the loss of dopamine — that have a high initial effect but over time lose their effectiveness.

“The problem is that patients on these dopaminergics eventually develop a side effect called augmentation,” Clemens said. “Their symptoms get worse while taking the current medication used for treatment.”

Classic RLS treatments act on a dopamine receptor known as D3 that has a suppressive effect in the nervous system. However, Clemens’ lab has shown in animal models that over time this medication leads to an increase of a different, excitatory receptor subtype, D1. This increase of the D1 receptor might be the cause of augmentation.

Clemens’ patent proposes a new treatment method that targets the increased D1 receptor levels in RLS patients suffering from augmentation, leading to reduced activation of D1 receptors while providing traditional therapy relief from RLS.

“Our lab postulates that this new compound will maintain long-term efficacy for RLS,” Clemens said. “If augmentation begins, we predict that we can reduce D1 receptor activation in patients and balance things back out, keeping the treatment effective.”

Clemens was awarded a grant from the North Carolina Biotechnology Center to run a small pilot study with a collaborator from the University of Houston using this new treatment method.

This work has gained the attention of a company that has interest in establishing a partnership where ECU’s patent rights may be used in combination with its existing drug formulation to bring relief to RLS patients suffering from augmentation.

Clemens added that the idea to apply for a patent came from ECU’s Office of Licensing and Commercialization.

“They not only brought the idea of patenting our research to my attention, but they also helped me through the process and handled all of the legal and technical aspects of filing a patent,” he said. “The patent would not have been issued without their help. I now know that it can be very beneficial to have experts in other areas come from different angles that make us think of other ways to use our work.”

Marti Van Scott, director of licensing and commercialization, said that finding commercialization opportunities for faculty research is an important bridge that brings science into the communities the university serves.

“It is a pleasure to work alongside our faculty to identify translational research opportunities that have potential to make a meaningful impact,” Van Scott said. “Licensing and commercialization works hard to identify skilled development partners to offer essential guidance for these translational activities. Whether it’s a new therapeutic or medical device, teaching or training method, or research tool, we are available to support the campus research and innovation ecosystem.”

While Clemens’ lab continues to work on its RLS treatment, Clemens said he’s also continuing to work on other medical treatments, including care for opioid pain tolerance.

Stefan Clemens, PhD, HdR, focuses his research on investigating the neural networks in the spinal cord, especially their role in neurological disorders, like RLS. He studies the role of dopamine in the spinal cord, and how the interactions between its different receptor subtypes may play a role in augmentation. At the RLS Foundation, Dr. Clemens serves on the Scientific and Medical Advisory Board where he chairs both the Brain Bank Committee and the Research Grant Committee.

Survey will help to guide treatment for malady that disrupts well-being for millions

The Restless Legs Syndrome (RLS) Foundation today, international RLS Awareness Day, has launched a research study on the challenges of living with RLS.

Through RLS patient and spouse/partner surveys, the RLS Patient Odyssey Survey II will evaluate treatment strategies, emotional well-being, relationships and lifestyle of people living with RLS, adding to the body of knowledge about the burden of disease and identifying focus areas for future education and research.

The RLS Patient Odyssey Survey II is the second survey developed by the RLS Foundation. More than 2,200 people participated in the first survey in 2013. Findings from the initial survey were published in the journal Sleep Medicine and disseminated broadly.

The current survey will gather updated and expanded data, and is particularly focused on the RLS patient experience with regard to treatments and medical care. People with RLS and their spouses/partners are encouraged to visit www.rls.org/odyssey to participate from Sept. 23 to Oct. 23.

Specifically, the study aims to:

• Understand the experiences of RLS patients with medical treatment and symptom management
• Provide data to researchers on the long-term burden of disease, including impact on spouses and partners
• Promote awareness that RLS is a serious neurological disorder
• Provide resources for RLS patients to facilitate decision-making with their healthcare providers

“RLS is a serious disease that can have a devastating impact on quality of life,” says Karla Dzienkowski, executive director of the RLS Foundation. “We have come a long way to advance treatments and research, but today's treatments are limited, and there is no cure. RLS patients still face significant daily challenges in managing the disease. This study will provide data to accelerate and focus our efforts to address these challenges and improve quality of life for RLS patients and their families.”

An estimated 12 million men, women and children in the US have RLS, and one in 33 adults (3%) needs daily medical treatment to manage symptoms. People with RLS experience an agitating and overwhelming urge to move their legs that can only be relieved by moving. RLS is at its strongest at night and severely disrupts sleep, robbing people of the ability to work and live normally while simultaneously raising the risk for hypertension, diabetes, heart disease and Alzheimer’s disease.

Results will be shared with the RLS community and the public in 2021, prepared for publication in the medical literature and presented at scientific meetings. Findings will also be shared with health policymakers in the RLS Foundation's legislative agenda and advocacy materials.

The RLS Patient Odyssey Survey II was designed by members of the RLS Foundation’s Scientific and Medical Advisory Board, Board of Directors, and staff. The survey is made possible by an educational grant from Arbor Pharmaceuticals.

Getting Healthcare during a Pandemic

The COVID-19 pandemic is changing the way we live in so many ways, including how healthcare services are being accessed: over the internet. If you’re sheltering at home to help stop the spread of coronavirus, but need to see a doctor, telemedicine—receiving medical care via digital technology—is a promising alternative to an in-person appointment.

According to a recent survey conducted by the Harris Poll for the telemedicine provider, Updox, 42% of people surveyed have used telemedicine (also called telehealth) since the start of the pandemic. 65% of survey participants said it is more convenient than in-office appointments, and 63% noted appreciation for not having to worry about being exposed to other potentially ill patients. Other benefits mentioned in the survey included how much easier they thought it was to schedule an appointment via telehealth compared to an in-office appointment (44%), and that follow-ups/communications were more streamlined (38%).

“Technically, there are three types of telemedicine: synchronous, asynchronous and remote monitoring,” explained Jeffrey S. Durmer, MD, PhD, Chief Medical Officer at NOX Health and RLS Foundation Board Member. “Synchronous refers to care that is provided with a live patient typically through a secure video link. Asynchronous, also known as ‘store and forward,’ refers to the act of collecting medical information, including examination data, imaging, laboratory results, etc., and then storing those items for reference later by a physician. Remote monitoring includes collecting behavioral and medical data using cloud enabled devices, software programs, and treatment hardware that can transmit data to remote providers. Remote monitoring can be either synchronous or asynchronous by nature of the patient being present or not, but usually it is asynchronous.” Tele-based programs on health education, behavioral modification, and psychological and social support also fit under the umbrella of telehealth.

Telemedicine for RLS

Dr. Durmer, whose research focuses on the neuroscience of sleep, says telemedicine is a great way for people with RLS to stay connected with providers, especially for sleep-related disorders since there are few sleep clinicians and centers located in the US.

“Telemedicine allows increased access to sleep care and improved management of sleep conditions by specialists. So, common issues like sleep disordered breathing, insomnia, restless legs syndrome, and circadian rhythm disorders are a natural fit for sleep telehealthcare,” he said, adding that more complex disorders may not be suited to telemedicine. “The use of telemedicine in sleep healthcare can augment much of our current face-to-face follow up using remote monitoring and synchronous tele-follow-up appointments.”

Prescriptions for medications usually can be obtained during a telehealth visit as well. Due to the coronavirus pandemic, the Drug Enforcement Agency is now allowing doctors to prescribe controlled substances and schedule II narcotics, such as opioids, during telehealth sessions as long as the medication is being issued for a legitimate medical condition in the clinician’s practice; the clinician follows all state and federal laws; and the telemedicine visit is synchronous, allowing for real-time, two-way communication.

“Outside of the current emergency decree, physicians are generally able to prescribe controlled substances by telemedicine if they have first had a face-to-face encounter with the patient prior to the telemedicine encounter,” said Durmer.

The future of telemedicine

Until now, telemedicine had some important caveats to consider. Stringent coverage rules, geographical issues, in which laws limit the practice of medicine across state lines, and other factors have created significant limitations for patient and providers. However, the coronavirus pandemic has pressured lawmakers to make some substantial changes. Now, the effort among many is to keep those previous barriers in the past permanently.

“Medical insurance plans have resisted the implementation of telemedicine, and prior to COVID-19, placed undue financial and operational burdens on clinicians and their patients in order to utilize telemedicine,” said Durmer. “Some states enacted ‘parity laws’ making it illegal for payers to pay less for telemedicine care than in-person medical care. Insurance companies have found ways around these laws by requiring physicians who want to get paid for telemedicine care to join insurance telemedicine networks. ese insurance-controlled networks often impose operational hurdles such as specifying the use of one electronic medical system, applying for approval to the insurance company telemedicine network and other obstacles that make it difficult for many physicians to even get started.” Medicaid and Medicare also put restrictions on telemedicine reimbursement, making it harder for recipients to engage, although after COVID-19, the government did issue a waiver that now enables greater participation.

“It took a devastating event—the COVID-19 pandemic—to rally the public and local legislators in an effort to extend the use of telemedicine as an equal and often better delivery model for US healthcare,” concluded Durmer. “Many organizations associated with healthcare policy are lobbying state and federal officials to maintain the current emergency telemedicine care guidelines beyond the COVID-19 pandemic, since it is clear that this methodology optimizes care delivery while maintaining a high standard of practice. An additional benefit of moving more care to the telemedicine environment is that by providing clear technology standards for this sort of practice, the ability to objectively measure patient care pathways, medical decisions, and patient outcomes become much more efficient and effective.”

September 23 is RLS Awareness Day!

This year we are celebrating RLS Awareness month by focusing on our advocacy program throughout September. We need your help to make sure everyone in Congress is #RLSAware. We’ve pulled together some ideas on how you can get involved to raise RLS awareness during September.

Here are the simple steps you'll take to get in touch with your representatives:

To find and contact your U.S. Senate Representative:

1. Visit the Senate website www.senate.gov
2. Conduct a search using the Find Your Senators pull-down menu in the upper right corner (select your state and click Go).
3. On the results page is a link to the Senator’s website, contact information, and links to an online contact form (forms vary by Senator).
4. To email: copy and paste your email script into the contact form found on their website, make edits and submit.
5. To call: choose an office location and follow the call script here.

To find and contact your U.S. House Representative:

1. Visit the House of Representatives website www.house.gov
2. Conduct a search using the Find Your Representative zip code search box in the upper right corner (enter your zip code and click Go).
3. On the results page is a photo of your Representative(s), links to the Representative’s personal website and online contact form, and a local map.
4. In the event your zip code overlaps with multiple congressional districts, the results page will include boxes for you to enter your zip code+4 or mailing address to find the correct Representative. If you need help finding your +4 zip code use the USPS Zip Code Lookup.
5. To email: copy and paste your email script into the contact form found on their website, make edits and submit.
6. To call: Look up Health Legislative Assistant (HLA) on partial list here and follow the call script here. If your HLA is not listed, call the office and ask to speak to the Health LA.

Keep an eye out for Foundation news and activities on our social media channels during September! And, after you contact your representatives please let us know here: https://www.surveymonkey.com/r/RLSAWARE

Take the RLS Patient Odyssey Survey to help advance RLS research, treatments and awareness!

On Sept. 23, RLS Awareness Day, the RLS Foundation will launch a new research study on the challenges of living with RLS. The RLS Patient Odyssey Survey II will evaluate RLS treatment strategies, emotional well-being, relationships and lifestyle, adding to the body of knowledge about the burden of disease and identifying focus areas for future education and research.

Specifically, the study aims to:

• Understand the experiences of RLS patients with medical treatment and symptom management
• Provide data to researchers on the long-term burden of disease, including impact on spouses and partners
• Promote awareness that RLS is a serious neurological disorder
• Provide resources for RLS patients to help facilitate decision-making with their healthcare providers on medical treatments to manage their disease

RLS Patient Odyssey Survey II is the second survey developed by the RLS Foundation. Findings in the 2013 first survey were published in the the Journal of Sleep Medicine and disseminated broadly. RLS Patient Odyssey Survey II will gather updated and expanded data in areas such as symptom management, experience with healthcare providers, and ways in which the disease affects daily life and emotional well-being.

The current survey is particularly focused on the RLS patient experience, especially with regard to treatments and medical care. The survey was designed by a work group comprised of RLS Foundation Scientific and Medical Advisory Board members Brian Koo, MD, William Ondo, MD and John Winkelman, MD; Board of Directors member Jeffrey Durmer, MD, PhD; and staff members Karla Dzienkowski, Maddie Lionberger and Zibby Crawford. The survey is made possible thanks to an educational grant from Arbor Pharmaceuticals.

RLS Foundation members and nonmembers alike are encouraged to participate in the study, which will consist of two online surveys: one for RLS patients, and one for partners. To participate, visit www.rls.org/odyssey from Sept. 23 to Oct. 23. See below for details. Survey results will be shared with the RLS community and the public in 2021, prepared for publication in the medical literature, and presented in scientific meetings. Findings will also be shared with health policymakers in Washington, DC in the RLS Foundation legislative agenda and advocacy materials.

“RLS is a serious disease that can have a devastating impact on quality of life,” says Karla Dzienkowski, executive director of the RLS Foundation. “We have come a long way to advance treatments and research, but today's treatments are limited, and there is no cure. RLS patients still face significant, daily challenges in managing the disease. This study will provide data to accelerate and focus our efforts to address these challenges and improve quality of life for RLS patients and future generations of their families.”

We need you to help advance RLS research, treatment and awareness by taking the Patient Odyssey Survey!

Your voice matters! You live with RLS every day, and your input is critical to helping researchers, healthcare providers and policymakers understand the impact of RLS on daily life and where to focus their efforts.

Here’s what you need to know:

• Access the survey starting on RLS Awareness Day: Wednesday, Sept. 23, at www.rls.org/odyssey.
• There are separate surveys for RLS patients and their spouses/partners (living in the same household).
• The patient and partner surveys take about 45 and 20 minutes to complete, respectively. You do not have to complete the survey in one sitting.
• You do not need to be a member of the RLS Foundation to participate.
• The surveys are anonymous; no individual identifying information is requested.
• We strongly encourage everyone to take the online survey, if possible. However, those without internet access or in need of accommodations can request a mail-in survey. Contact the RLS Foundation at info@rls.org or 512-366-9109.
• The last day to participate is Friday, Oct. 23.

Mark your calendar for Sept. 23 to take the survey, and please share the link with others. You can also visit www.rls.org/odyssey to download a one-page flyer to hand out or post on bulletin boards in your community. Thank you!

Questions? Contact Maddie Lionberger, Research Coordinator, at maddie@rls.org or at 512-366-9109.