Fred Burbank M.D. discusses a breakthrough new product to treat Restless Legs Syndrome “RLS.” This innovative device is called ‘Relaxis™’ and could shift the treatment paradigm for RLS patients.
It is a “First In Class” device. It is also the first FDA-cleared, prescription, non-pharmacologic device to improve sleep quality in patients with primary Restless Legs Syndrome (RLS).
Dr. Burbank describes how Relaxis came to be: “I was watching television one night with my wife,” he says. “And up on the TV screen came an ad for one of the drugs to treat RLS.”
As Burbank listened to the ad, he was convinced that he had RLS. He could relate to his own discomfort and inability to get to sleep. “I had put it down to being part of the general body aging,” he recollects. “But the TV ad encouraged me to read more about RLS.”
The study of sleep disorders was part of Dr. Burbank’s clinical specialization in psychiatry during his residency training at Stanford University. “Bill Dement, the father of the sleep movement throughout the United States, was one of the professors there. And so, in addition to learning psychiatry I got to learn about sleep disorders.”
As it turned out, the combination of psychiatry and sleep disorders had Dr. Burbank conceptualize RLS differently. This different understanding perhaps formed the basis of the Relaxis system.
“The first thng I knew from my own experience was that as soon as I stood up and walked around a bit, the sensations of RLS went away,” he recounts. “When I had an attack, each time I would stand up they would simply evaporate.”
As Dr. Burbank noticed himself consciously and sometimes aggressively massaging his legs and thighs before finally being forced to stand up, two thoughts struck him. One, standing up provided a real sensory input and broke the RLS attack. Two, the action of rubbing his legs and other voluntary movements prior to standing up diminished the dysphoria of RLS.
“I conceptualized the disorder as being within the brain and not within the leg,” says Dr. Burbank. “And that one might be able to diminish the dysphoria of RLS by applying something while in bed so sufferers can get to sleep – that has always been the primary objective.”
“We then studied the whole range of sensory inputs,” explains Dr. Burbank. “Sound, light, squeezing, thumping and vibration. Of these, most folks could focus best on vibration during the RLS attacks.”
And so they developed a pad with vibrating motors that could vibrate at different intensities – intensities that could be set and adjusted by the patients themselves. And finally, the pad should gradually and slowly go to the “off” setting after half an hour so as not to jar the patients awake, should they have fallen asleep. “As you know,” explains Dr. Burbank, “the cessation of sensation while asleep can be as alerting as the start of one.”
This was the genesis of the Relaxis system, a device that applies a real sensory input to the patient’s brain, much like the sensory input patients receive when they stand up to relieve their RLS attack. However, because the device provides sensory input for patients in the comfort of their own bed, it allows them to remain in a state of restfulness and get back to sleep.
The Relaxis pad was developed to provide vibration to the legs, the most troublesome area for an RLS patient. The device is stored in or next to the bed so that it can be quickly and easily placed under the legs when an RLS attack starts.
“We then progressed ahead on to two parallel, prospective, randomized double-blinded trials,” elaborates Dr. Burbank. Using sham pads, one that made a sound and another that incorporated a light (but generated no heat), they conducted trials and submitted them to the FDA as part of a De Novo application, reserved for “novel devices” that do not have any other product on the market to compare with – Relaxis is truly a “First in Class.” The two clinical studies showed that Relaxis was better than the shams at improving quality of sleep in primary RLS patients. Additionally, they gathered data to compare their shams to drug placebos in order to show through meta-analysis that the shams were comparable to the placebos used in drug trials and that the results from Relaxis were similar to drugs for improving sleep quality in primary RLS patients. Unlike drugs, adverse effects were mild to moderate and resolved on their own without medical intervention after simply discontinuing use of the device. FDA cleared Relaxis for improving sleep quality in patients with primary RLS in December 2013.
This leads to the question, how does Relaxis actually work? What is the science behind the therapy?
“The overriding view is that RLS is a phenomenon that occurs within the brain when the patient is sleepy,” says Dr. Burbank. “We see this in the same way as dreams occur. The brain can sense or imagine something when it is not there. In a sense, it is like a hallucination that occurs when you are partially asleep but not totally asleep.”
Dr. Burbank explains that as the brain communicates with itself, it causes the dysphoric sensations experienced by RLS patients. Real sensory inputs, from sources such as standing or walking, can override and reduce this dysphoria within the brain.
“As a company, our goal is to find the most efficient way of providing this sensory input to the brain when the patient has an attack,” says Dr. Burbank. “Getting up and walking around is not compatible with sleep. Using Relaxis, a patient suffering an RLS attack can stay in bed and go to sleep – drug free.”
Is there a definitive paper on RLS that clearly sets out what this disorder is?
“I don’t believe there is,” says Dr. Burbank. “The disorder has been poorly understood.” He cites instances of how the repurposing of various transmitter drugs to cure RLS have not always worked. “People talk about this as a sensory or motor disorder, because people move their legs when they have an attack,” he says. “RLS is a sensory experience inside the brain, period. People consciously move their legs because movement, which is a real sensory input, breaks the attack and reduces the discomfort.”
So then, what would be the best methodology to diagnose RLS?
Dr. Burbank is firm in his opinion. “The only method to diagnose RLS is a subjective paper and pencil test. One has to talk to the patient to hear his or her specific description to make the diagnosis. One can use the test to get an estimate of the magnitude of the disorder.” The IRLS scale, asserts Dr. Burbank, is the standard for determining the magnitude of RLS in patients. On a scale of zero to 40, this scale sets out a score of 0-10 as mild, 11-20 as moderate, 21-30 as severe, and 31-40 as very severe.
How does Dr. Burbank think the Relaxis system will change the world for RLS patients?
“It gives them a first line of treatment with no risk of the potpourri of side effects caused by brain interfering drugs. Plus, patients who are already on drugs can add this to their regimen without adding anything at all to their side effects.”
Fred Burbank, M.D. is the founder of three successful medical device companies – Biopsys (acquired on the public market by Johnson & Johnson), Vascular Control Systems (acquired prior to pivotal clinical trial by Johnson & Johnson), and SenoRx. He is a named inventor in over 80 pending and issued patents. Dr. Burbank received his M.D. and B.A. degrees from Stanford University.