Restless Legs Syndrome Foundation Blog

April 11, 2024

When Should I Visit an RLS Quality Care Center?

This article is based on the QA from the webinar titled “When to Visit an RLS Quality Care Center,” presented by Avinash Aggarwal, MD. Dr. Aggarwal is the Quality Care Center Director at the University of Pittsburgh Medical Center in Pittsburgh, PA. The complete webinar recording can be found in the Member Portal on www.rls.org.

1. What is the desired outcome of a visit to a Quality Care Center? Reduced symptoms? Lifestyle changes? Dietary changes? Exercise?

When visiting a QCC, all of these issues are addressed. A thorough medical history of past and present medications, including supplements and over-the-counter medications, will identify potential RLS triggers. Physicians and patients work together to determine the desired outcome of their visit.

2. How do you ensure you will get assigned to the expert who can treat your severity of RLS?

Only the providers listed on the RLS Foundation website at www.rls.org/treatment/quality-care-centers are certified RLS experts. Patients should thoroughly research each physician on the Foundation website and ask for an appointment with the provider that is close in proximity and is a fit for all healthcare needs.

3. Which medical records do you bring to your first appointment?

Bring all medical records available and send them ahead of time, if possible. Medical records include physician notes, a list of previous medications and their side effects, current medications, and test results, specifically results from a complete iron panel.

4. What does a QCC offer me if I have a local doctor and have already tried all known classes of medications?

QCC providers think outside of the box, considering the patient’s complete history and a comprehensive neurological examination. All patients are administered the International Restless Legs Syndrome Study Group Rating Scale (IRLSSG) on both their initial and subsequent visits. With adequate treatment, the severity rating can decrease from high to extremely low, sometimes zero. As experts in the RLS field, QCC certified providers can identify triggers and treat patients based on the latest guidelines.

5. What should I expect from the first visit, and can follow-up visits be done remotely?

The first visit is typically about an hour long. A QCC provider performs a thorough history and examination, reviews the current treatment plan, and discusses available therapies. The International Restless Legs Syndrome Study Group Rating Scale (IRLSSG) is also administered on the first visit to gauge RLS symptoms. A tailored treatment plan is developed for the patient utilizing a shared decision-making process. Follow-up visits can be done remotely.

6. How can we find the QCC closest to where we live? Is there a list of locations?

There are 10 QCCs in the United States and two in Europe. A list of all centers as well as contact and appointment information is available on RLS Foundation website. If you need assistance, contact the RLS Foundation at info@rls.org.

7. How long is the wait time for an appointment?

Every center is different and wait times are variable. At the QCC in Pittsburgh, there is a cancellation list that reduces waiting time.

8. What training and expertise do the QCCs have that sets them apart?

QCC physicians are board-certified in sleep medicine and many are neurologists. All QCC providers abide by the latest RLS treatment guidelines and provide comprehensive care. QCC physicians undergo a rigorous process to be credentialed.

8. If I have visited a QCC in the past, are there any reasons I should visit one again?

If symptoms are not controlled, if there are significant side effects, or if a patient is not satisfied with disease control, another visit to a QCC may be considered.

10. Are Canadians able to visit the QCCs?

QCCs welcome patients from around the world. Patients should speak to their insurance company to determine if there is coverage or if there will be out-of-pocket expenses.

11. Can out-of-state quality care centers continue with opioid therapy?

Opioid therapy coverage depends on individual state and insurance company regulations.

12. Is there a QCC available for consultations and treatment for out-of-state patients who are not able to travel?

Since COVID, some out-of-state appointments are available. Coverage will depend on the insurer and out-of-pocket expenses may apply.

June 28, 2023

Should Cannabis be Considered an RLS Treatment?

By Adrianna Colucci, RLS Foundation Administrative Assistant

Research examining the potential role that medical cannabis can play in treating medical conditions and sleep disorders is increasing within the United States. Cannabis is a plant containing active ingredients that is classified as a psychoactive drug when ingested, inhaled, or applied.1 Under federal legislation, cannabis is illegal and defined as a Schedule I drug: however, states have individual laws regarding its recreational and medical use. While medical marijuana is not among the approved treatments for RLS, there are individuals who have anecdotally had success in managing symptoms using the drug with or without the supervision of their healthcare providers.

WHAT IS CANNABIS?

Over 450 chemical compounds have been identified in cannabis. The two most commonly referred to compounds, or cannabinoids, are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The human body produces endocannabinoids naturally as an important part of regulating the circadian sleep cycle and maintaining homeostasis, a state of balance among biological systems in the body.2 These endocannabinoids bind to cannabinoid receptors in the body, primarily CB1 and CB2 receptors. These are found predominantly in the central and peripheral nervous systems and in immune tissues.1 When THC or CBD are introduced to the body, these cannabinoids interact with the endocannabinoid receptors differently, producing distinct reactions.

DIFFERENCES IN CLASSIFICATIONS OF CANNABIS

THC is the main psychoactive component in marijuana and interacts primarily with the brain’s CB1 receptors, eliciting a euphoric or “high” sensation. THC can be used medicinally to prevent nausea that occurs in chemotherapy patients, promote appetite and can help treat certain medical conditions. Some of the adverse effects include short-term memory loss, increased heart rate, loss of coordination, and hallucinations. Longer term, there is a risk of addiction, along with impaired cognition and brain development.

CBD does not produce the same euphoric feeling as THC. How CBD interacts with cannabinoid receptors is not well understood, but studies suggest it can provide relief from anxiety or pain. There are no significant neurological effects associated with CBD, and it can help increase sedation to help insomnia. Some of the adverse effects include decreased appetite, fatigue, drowsiness and an increased risk of infection.2

CANNABIS AND SLEEP

A study conducted in 2017 looked at the effectiveness of medical cannabis as a substitution for pharmaceutical options for pain, anxiety and sleep.3 Of the 1,513 participants who took part in the survey, 76.7% indicated the ability to reduce their regularly prescribed opioids after incorporating medical cannabis into their management plan. Furthermore, 65.2% reduced their sleep medications. Other studies show that administration of THC is beneficial on a short-term basis, but developing tolerance and withdrawal can eventually cause sleep disturbances.

Although drowsiness is a side effect of CBD, findings vary on its effectiveness for treating sleep disorders. CBD was used in a large case study that observed its efficacy in a group of 72 adults presenting with anxiety, of which 25 suffered from inadequate sleep.4 Most patients were prescribed 25 milligrams, although those with severe cases were prescribed 50-75 milligrams. For those with anxiety, the capsule was administered early in the day, and for those with sleep concerns, it was given in the evening. Sleep quality was documented according to the Pittsburgh Sleep Quality Index. In the first month, the quality of sleep improved in 66.7% of participants, while 25% experienced worsening sleep issues. These numbers fluctuated in the following month when only 56.1% reported an improvement in sleep and 26.8% reported worsening problems. Though sleep scores demonstrated a mild improvement, CBD showed a more consistent benefit for anxiety than with sleep issues.

CANNABIS AND RLS

There are very few academic studies that investigate the correlation between RLS and the effects of medical cannabis directly. Observational data published in 2020 by Dr. Imad Ghorayeb examined twelve predominantly male RLS patients, ages 31 to 69.5 Eleven of the twelve participants reported an improvement in RLS symptoms after smoking cannabis or using CBD oil in addition to their current treatment medications. These improvements ranged from 60% to 100%, with the last participant noting no improvement. Due to concern about psychoactive effects and the potential risk for abuse, three of the individuals switched to CBD oil, noting the increased effectiveness of smoking cannabis versus a topical treatment. This data shows the need for further clinical trials and research on the efficacy of cannabis and CBD.

The observations of one of the RLS experts based in California, where marijuana has been legal and widely used for many years, is that inhaled marijuana most often relieves RLS symptoms after only 1-3 inhalations. This effect typically onsets within less than 5 minutes but only lasts 1-2 hours. Edible marijuana, even in high doses is rarely effective in relieving RLS symptoms. CBD may sometimes promote sleep but does not improve RLS symptoms.

CONCLUSION

Cannabis has been cultivated by numerous cultures, spanning centuries for its medicinal properties. Based on a lack of clinical data, further research is required before cannabis can be recommended for routine use for RLS. If you are thinking of integrating cannabis into your treatment, be sure to consult your doctor, as it can interact with other drugs. There are various forms of cannabis available including vapor, smoke, edibles, plant resin and oil extracts. Consult with your physician to determine which method and dosage may be right for you.

SOURCES:

1 Kaul M, Zee PC, Sahni AS. “Effects of Cannabinoids on Sleep and their Therapeutic Potential for Sleep Disorders.” Neurotherapeutics. 2021 Jan;18(1):217-227. Doi: 10.1007/s13311-021-01013-w. Epub 2021 Feb 12.

2 Bainbridge, Jacqueline Pharm D. FCCP, MSCS, FAES. “Medical Marijuana/ Cannabis: The Proof is in the Pudding” Webinar. 2022.

3 Piper BJ, DeKeuster RM, Beals ML, Cobb CM, Burchman CA, Perkinson L, Lynn ST, Nichols SD, Abess AT. “Substitution of medical cannabis for pharmaceutical agents for pain, anxiety, and sleep.” J Psychopharmacol. 2017 May;31(5):569-575. doi: 10.1177/0269881117699616. Epub 2017 Apr 1 PMID: 28372506.

4 Shannon S, Lewis N, Lee H, Hughes S. “Cannabidiol in Anxiety and Sleep: A Large Case Series.” Perm J. 2019;23:18-041. doi: 10.7812/TPP/18-041. PMID: 30624194; PMCID: PMC6326553.

5 Ghorayeb I. “More evidence of cannabis efficacy in restless legs syndrome.” Sleep Breath. 2020 Mar;24(1):277-279. doi: 10.1007/s11325-019-01978-1. Epub 2019 Dec 9. PMID: 31820197.

March 5, 2021

Stefan Clemens, an East Carolina University (ECU) associate professor at the Brody School of Medicine’s Department of Physiology, was awarded a US patent for his novel method of treating restless legs syndrome (RLS), which could lead to more effective care over a longer period of time for patients.

RLS is frequently treated with dopaminergic drugs to replace or prevent the loss of dopamine. While these drugs can deliver a high initial effect, they often lose their effectiveness over time and symptoms can worsen, a side effect known as augmentation. Classic RLS treatments act on a dopamine receptor known as D3, which has a suppressive effect in the nervous system.

Clemens’ animal models show that over time the 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, which he received in late August 2020, 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.”

Using a grant from the North Carolina Biotechnology Center, Clemens and a collaborator from the University of Houston will run a small pilot study of the new treatment method. His work also 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 for treating augmentation. “The patent would not have been issued without their help,” said Clemens, who is also working on medical treatments for opioid pain tolerance. “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.” Clemens is a member of the Foundation's Scientific and Medical Advisory Board and is the Chair of the Research Grant committee.

October 1, 2020

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.

September 18, 2020

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.”