Restless Legs Syndrome Foundation Blog

Research Will Evaluate Nighttime Agitation and RLS

Thursday, June 21, 2018

June 21, 2018

By Kris Schanilec

For many people who have Alzheimer’s disease, evenings are difficult. Right around sundown, uneasy feelings and confusion start to flow. The person may become forgetful, agitated – even aggressive, and start pacing or wandering. These symptoms can last through the night and make it tough for anyone in the household to get a good night’s sleep.

Could it be that these behaviors – known as nighttime agitation, or “sundowning” – are caused by RLS? And could treating the RLS lessen the nighttime agitation symptoms?

Researchers led by Kathy Richards, PhD, at the University of Texas at Austin are working to answer these questions. Dr. Richards and co-investigator Christine Kovach, PhD, from the University of Wisconsin-Milwaukee have been awarded a $3.9 million, five-year grant from the National Institute on Aging to evaluate whether there is an association between nighttime agitation and RLS in people who have Alzheimer’s disease.

“Nighttime agitation is the No. 1 reason why people with Alzheimer’s cannot be cared for at home,” says Dr. Richards. “If we can find a better and more precise way to treat nighttime agitation, we can improve the quality of life for many persons who are living with Alzheimer’s disease.”

Nighttime agitation is often treated with powerful antipsychotic drugs, which are only moderately effective and carry with them serious risks, such as falls, stroke and death.

Because nighttime agitation has a strong circadian component and shares symptoms with RLS, Dr. Richards and others have long postulated that for some people, undiagnosed RLS could be the underlying cause. In a previous study led by Dr. Richards, researchers examined symptoms in 59 people who had Alzheimer’s disease and nighttime agitation. They found that 24 percent of participants also had RLS.

In the current research, the team will validate this result in a pilot study – an eight-week, double-blind, randomized controlled trial with 136 long-term care residents who have nighttime agitation and RLS. Participants will receive either gabapentin enacarbil (Horizant, an FDA-approved medication for treating RLS) or a placebo. Data from the study will also help discern the effectiveness, safety and optimal dosage of gabapentin enacarbil for treating nighttime agitation, as well as whether the frequency of RLS symptoms may be linked to nighttime agitation.

The researchers will use a tool newly developed by Dr. Richards called the Behavioral Indicators Test-Restless Legs. This test includes a brief 20-minute observation and simple set of questions for caregivers. Previous studies have shown the tool to be an effective way to diagnose RLS in people who have Alzheimer’s, and one that has potential for future use with children and others who don’t have the ability to report their symptoms.

RLS Foundation Executive Director Karla Dzienkowski visited the University of Texas in May, where she gave a presentation about RLS and met with Dr. Richards’ team to extend the RLS Foundation’s support for the research endeavor. “Cognitively impaired seniors with RLS may have difficulty expressing RLS symptoms causing an inability to sit or lie still during the evening or nighttime hours,” says Dzienkowski. “This study will ensure seniors with cognitive impairments are accurately diagnosed and receive proper treatment to manage their RLS symptoms.”

Dr. Richards emphasizes that while there is no evidence suggesting that RLS causes Alzheimer’s, the study may show that it’s important for caregivers of people with any type of dementia to watch for possible signs of RLS that can then be treated to potentially reduce nighttime agitation.

It all comes down to quality of life for people who have dementia, says Richards. “I hope they will be more comfortable, and that they – and their caregivers – can get a good night’s sleep.”

Kathy Richards, PhD, is a member of the RLS Foundation Scientific and Medical Advisory Board. Read more about her research on the University of Texas at Austin School of Nursing newsletter.

How the 2018 Tax Reform Affects Your Giving

Wednesday, June 13, 2018

“Does the new tax law take away my tax benefit when I make a contribution to the Foundation?”
At the RLS Foundation, we have been hearing this question from many of our donors, supporters, members and friends. We consulted with tax experts, and based on their analysis, we believe the correct answer is, “Probably not, but it depends.” In fact, the new tax law has actually made charitable giving more affordable for many donors!

Don’t believe the headlines

You may have heard reports that charities like the RLS Foundation risk losing millions of donations because more taxpayers may qualify for the newly doubled standard deduction (up from $12,000 to $24,000 for married taxpayers filing jointly, with an added $1,300 for each spouse age 65 or older).
But depending on their circumstances, this higher standard deduction could mean donors have more money available to support their favorite causes. Moreover, the newly lowered tax brackets mean that donor incomes may be taxed at lower rates overall.
If the new law generates greater tax savings for someone, then part of those savings is available to donate. The surprising result may be that the new tax law actually increases charitable giving.

More advantages to giving!

Meanwhile, the new tax law has created or maintained other tax advantages that specifically benefit charitable giving:

There is a cap on how much of a contribution may be deducted in a year when comparing that gift to the taxpayer’s income. The new law raised that cap from 50 percent of income to 60 percent, which could allow for a larger annual tax deduction.
Also, people age 70 1/2 or older who must take an annual required minimum distribution (RMD) from their IRA can continue to make a qualified charitable deduction (QCD). This allows them to make a contribution of up to $100,000 directly from their IRA to a charity – which can satisfy part or all of their RMD (or exceed it) but not count as taxable income. And, they can still take a standard deduction on top of it.
The new tax law continues to offer the opportunity to donate appreciated stock and deduct the increased value, subject to a 30 percent limit of taxpayer’s income. The amount over the 30 percent of income can be carried over for up to five years and deducted in future years.

Keep on believing

The question every donor should ask him or herself is: “Why do I give?” At the RLS Foundation, we feel (and studies have shown) that donors give first and foremost because they believe in the causes they support.
Getting a tax benefit is a nice bonus, but what motivates supporters like you to make a gift, whether it’s $25, $250, or even $25,000 or more, is knowing that you’re doing your part – connecting personally to a mission that’s important to you. We give because we care. The new tax law doesn’t change this fact at all.
So, our advice to all our supporters is to look past the gloomy headlines from last fall and winter. Speak with your tax advisor about ways to maximize your tax benefits. ... And, when it comes to our work to find a cure for RLS (and the other worthy causes you support) – keep on believing!
The possible tax advantages of charitable giving described above are illustrations only and may not apply to specific taxpayers’ circumstances. To determine whether you may have tax benefits associated with charitable giving, consult with a certified public accountant, tax return preparation specialist or other qualified financial adviser.

A Guide to Meeting with Your Legislators

Tuesday, June 12, 2018

Webinar: Legislative Update + Opportunities for Congressional Outreach

Tuesday, June 12, 2018

Excerpts from the Q&A

In April 2018, the RLS Foundation hosted the webinar “Legislative Update and Opportunities for Congressional Outreach,” presented by Dane Christiansen, MBA, vice president of the Health and Medicine Counsel of Washington. Mr. Christiansen has worked in government relations since 2004, and specializes in advancing medical research, treatment development, and patient access related policy goals for communities impacted by rare, chronic, and life-threatening medical conditions.

The following questions and answers are based on the webinar. Visit the online Member Portal or the Advocacy page of the Foundation's website to view the full presentation. To see a listing of all of the Foundation's upcoming webinars, visit www.rls.org.

Q: How can I monitor what legislation is being considered in Florida (and other states) and with the federal government?

A: That’s a very good question. If you are looking at what the federal government is doing, there is something called the Congressional Record that you can Google and sign up for that will tell you whenever a bill is introduced or whenever Congress is making a statement on something. But you might feel like that’s drinking from a firehose in terms of how much information you’re getting. There’s also a website called congress.gov which lists all of the bills that get introduced.

Every state is different, and every state has a different process. But the same way that we said that there is a house.gov and there is a senate.gov, where you can find your members of Congress, I know for a fact that that the Florida legislator has a floridasenate.gov and a floridahouse.gov. So, there is a Florida version of that on the local level, and you can similarly use that to identify your local members of Congress. I would encourage anybody to think about approaching their local members of Congress the same way that they would approach their national members of Congress. If the Florida legislator is considering approaching anything, rather than analyzing every bill that comes out, why not take time to write them a letter or send the local office or local state senator an email and say, “I just wanted you to know about RLS and how RLS patients use opioid-based mediations.” The same thing that you do for your members of Congress and your senators, would definitely similarly apply to your state senator and state representative no matter what state you’re in.

Q: What is the most effective form of communication with legislators? A mailed letter, a meeting, a phone call, or an email?

A: Some of you may recall if you did a letter in the past that HMCW helped with, we asked folks to mail those letters to us, and then we would hand-deliver them to Capitol Hill. The reason we asked you to send your letters to us is because you can’t send mail directly to Capitol Hill. Ever since there was the anthrax scare over a decade ago, mail goes to a processing facility in Ohio where it is radiated for a month. If you send your member of Congress a letter, it’s going to show up six weeks later and it’s going to be falling apart. So, if you send it to us, we can hand-deliver it directly to them. Of course, how things go nowadays, calling the office and also emailing the office is by far the easiest way to communicate with these folks. They don’t tend to hand out a lot of staff emails, but if you have that first meeting with the office in the spring or summer, you’re going to get a business card from that person. I would encourage you to occasionally email them to follow up. If you ever wanted to get information to them, or if you ever wanted to send them a letter, an email would be the easiest way to get a hold of them.

Q: To what extent can federal legislation override state laws, or is there a need to also be monitoring state efforts?

A: This is something that interestingly comes up more often these days. Federal law supersedes state law. The states can do as they see fit, but if the federal government passes something, it supersedes anything the state has done. The federal law is the primary law of the land.

Just to give an example, if the states said, “We’re not going to prescribe opioids to anyone,” and the federal government said, “You must prescribe to whomever the doctor thinks the right person to get it,” then the state would have no ability to not prescribe opioids or to advance that rule. The area where this becomes a little more murky is that the states do have latitude to do things wherever the federal government is not clear. So, if the government says, “This is our criteria for regulating prescribing,” there is nothing that would stop a state from adding additional rules on top of that, provided that they didn’t contravene or contradict what the federal government laid out. Anywhere the government is not specifically doing something, the state is allowed to take some form of action.

It is important to stay vigilant and to monitor what your states are doing, but right now a lot of the eyes are on the federal government in terms of what is going to take place with opioid coverage and access policy.

Q: How do you go about scheduling an appointment with a legislator? Do I organize it myself for the meeting and is it best to go as a group?

A: It’s better to go as a group. If you want to personally go into an office, that’s great. We definitely want the office to see somebody from the community. If you have an online support group that you work with, if there are others that the Foundation can connect you with that are local, it is very much in your interest to do this together. There might be a case, where they are four of you and you are from a particular area, like Philadelphia, but each of you may have a different congressperson even though you live near each other. Why don’t all four of you go and visit each those four offices together? That would be the ideal way to do it.

Q: Do you need to have specific proposed regulations to reference when you when you visit your legislator?

A: No, and this is why I would refer you back to the Statement of Principles document. The key thing would be to say, “Hey, we know that there are a lot of competing proposals right now. We know that Congress is taking a very broad look at this. There are many different ideas about how to move forward. We just want you to have facts from the RLS community. This is our Statement of Principles, and we ask you that anything that is moving through the legislative process aligns with these principles so it does not harm the RLS community.” That’s the value of having the North Star of the Statement of Principles document.

Q: Do you really think a carve-out for RLS in opioid legislation is possible?

A: Yes, but it’s very likely that the language will a little bit broader than mentioning a specific condition. For example, we already know that there is a potential carve out now for chronic pain, but they don’t list different conditions that might cause chronic pain. They just say “chronic pain.” Similarly, they will probably have a broader phrase, something like “neurological disorders,” that will capture RLS and also potentially other communities that use opioids in the same way – low-dose, chronic use to disrupt signals coming from within the brain itself. So, definitely yes on a carve out, but probably with the caveat that they might not mention the condition specifically, but instead an overall class of disorders that will capture our community.

Q: Is opioid treatment of RLS becoming more or less accepted by treatment providers?

A: I would say definitely more accepted. The scientific literature is pretty clear on this. One of the reasons that we talk about the importance of funding medical research is that we want a cure, we want better treatment options. But for right now, there is a growing awareness of what the proper treatment protocols are. Part of that is that these scientists read these medical journals and they get continuing education. There have been many journal publications recently and much research put out about how this is the proper care for RLS patients.

Just as an example, when we were doing meetings for Hilde, there was an office that said, “Is this true? Do they really give RLS patients methadone? I don’t know about this.” They said they were going to look at our information. The next day the American Academy of Neurology came to visit them, and Hilde asked, “Is it true that RLS patients take methadone? Is this the right way to do it?” And all of the doctors that were there with the American Academy of Neurology said, “Oh, absolutely. That is the clinical judgment, and that is the way it is currently done.”

So, while there is more scrutiny on opioid prescribing these days because of the tremendous amount of sensitivity to what is going on in the country, in terms of healthcare professionals, there is a growing awareness that this is a proper standard of care.

Q: Do you foresee that additional opioid lobbying in FY 2019 will be necessary to keep opioids as a treatment options for severe cases of RLS?

A: Yes, and I would go back to the “at the table or on the menu” phrase. If we aren’t advocating and we aren’t speaking out, I do believe that there is a real chance that Congress could do something that’s arbitrary or restrictive or harmful. They did already take a step and carve out chronic pain. They have not taken a similar step for RLS, but they need to. And we should have every expectation that they will if we make our voices heard, educate them, and tell them what is needed.

New Findings on RLS

Friday, April 27, 2018

New Connection between Restless Legs Syndrome and Changes in Brain Structure

In a new study published in an online issue of Neurology, researchers at Pennsylvania State University revealed a connection between patients with restless legs syndrome and changes in brain structure, specifically parts of the brain that process sensory information.

"These structural changes make it even more convincing that restless legs syndrome symptoms are stemming from unique changes in the brain, and provide a new area of focus to understand the syndrome and possibly develop new therapies," said study author Byeong-Yeul Lee, PhD, who worked on the research team while at Pennsylvania State University before moving onto The University of Minnesota in Minneapolis. James R. Connor, RLS Foundation Scientific and Medical Advisory Board member, is also an author on this work.

During the study, MRI brain scans were performed on 28 people with severe RLS (who had the disorder for an average of 13 years) and a control group of 51 people without RLS. These scans showed that patients with RLS had an average of 7.5 percent less tissue thickness in the somatosensory cortex, the area of the brain that processes thing like touch, pain, movement, position and temperature.

Interestingly, the RLS patient group also had a decrease in the brain where nerve fibers connect the two hemispheres of the brain. While this study does not prove causation, it does provide a new piece to the puzzle about where to focus RLS research and treatments.

“I think the work is important at two levels,” Dr. Connor said. “The data continue to support that there are differences in the RLS brain --- these types of studies continue to hammer home the idea to the general public and health professional communities and funding agencies that RLS is a biological disorder and not anxiety or something without a biological basis. Additionally, this study is important because it ties imaging to the area of the brain that involves processing sensory information. We don’t know if the RLS symptoms start at this area of the brain or elsewhere in the brain, but for the first time there is a clear change in the brain that interprets sensory input.”

The original Neurology article is available for purchase online.

Spotlight: Lisa Marie Smith

Wednesday, April 25, 2018

Guest Blogger: Bjorn Fredrickson

Monday, April 23, 2018

Restless Legs Syndrome Foundation Blog

Research Will Evaluate Nighttime Agitation and RLS