Quell Customers to Receive $3.9 Million in Refunds

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission is sending refunds of nearly $3.9 million to consumers who bought Quell, a wearable nerve stimulation device touted as a drug-free treatment for chronic pain. The refunds are part of a settlement the FTC reached in March with NeuroMetrix – the maker of Quell – over deceptive advertising.

An FTC complaint alleged that NeuroMetrix and CEO Shai Gozani advertised Quell as an effective treatment for fibromyalgia, osteoarthritis, sciatica, shingles and other chronic pain conditions without reliable scientific evidence to back it up.  

Two clinical studies cited in Quell advertisements had “substantial flaws,” according to the FTC, while a third study was based on a marketing survey conducted by the company to “generate potential advertising claims” about the device. The FTC also objected to claims that Quell was “clinically proven” and “FDA cleared” for chronic pain relief.

“Defendants engaged in their unlawful acts and practices repeatedly over a period of more than four years, continued their unlawful acts or practices despite knowledge of complaints that advertising claims for Quell were not substantiated and went beyond claims the FDA allowed for similar devices, and continued such deceptive advertising unabated until FTC staff notified them it would recommend law enforcement action,” the FTC complaint said.

Neurometrix settled the case – without admitting or denying the allegations – for $4 million. The company also agreed to stop claiming that Quell provides relief for chronic or severe pain beyond the knee area where the device is worn.

The FTC is using the settlement funds to send 2,144 refund checks and 67,998 refunds via PayPal to Quell purchasers. The average refund amount is $55.10 per customer. Consumers who do not receive a refund, but believe they should, should contact the refund administrator, Rust Consulting, at 1-866-403-6545.

The Quell device sells for $299, while an older version is available for $199. Quell is sold over-the-counter, does not require a prescription and is not usually covered by insurance.

NeuroMetrix recently announced that Quell will be used in a clinical trial on the use of transcutaneous electrical nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy  The study is being conducted at the University of Rochester School of Medicine and Dentistry, with funding from the National Institutes of Health. Quell is also being evaluated in a small study as a treatment for fibromyalgia.

Meeting the Doctor Who Helped Me Most

By Barby Ingle, PNN Columnist

In honor of September being Pain Awareness Month, I wanted to give homage to the doctor who helped me most over the past 20 years. He was in my life for about 6 years of this journey, before he retired, but he has given me tools for a lifetime.

When I arrived at Dr. Robert Schwartzman’s office for the first time, I was excited. I had met him a few years prior at a medical conference, where he agreed to treat me. Dr. Schwartzman is one of the world’s leading experts on Reflex Sympathetic Dystrophy (RSD), also known as Complex Regional Pain Syndrome (CRPS). Due to high demand from other patients, there was a waiting list to see him.

I was in my wheelchair and had made the trip to Pennsylvania from Virginia, where I was staying with my sister and her husband. At the time, I was hurting all over and many of my symptoms were flaring due to the travel.  I had many types of pain going on: burning, stabbing, electric, shooting, deep, surface and bone pain. I was dizzy and felt nauseated.

My name was called and my sister and I went to the exam room. The nurse was very nice and asked all the right questions. She had me put on a gown. Then we waited.

When Dr. Schwartzman walked into the exam room to see me, he was followed by about 9 student doctors. His first words were, “Now she has Reflex Sympathetic Dystrophy. Anyone should be able to see it at first glance.” He then began pointing out all of the symptoms I had from the RSD. He knew things before I even said anything.

The doctors saw the blanching in my skin. From my face to my feet, I had discoloration. I never paid that much attention to how bad it had gotten over the years; maybe because it happened over time. I took pictures of it, but did not know that it meant RSD had spread to those areas.

The most severe burning pain was on the right side of my body. I had all the other types of pain on the left side, but the atrophy and lack of coordination were not as bad.

DR. ROBERT SCHWARTZMAN

When Dr. Schwartzman began to do neurological testing on both sides, I felt the pain. The right side was worse, but the left side was definitely affected. He discussed me being diagnosed incorrectly by my other doctors with Thoracic Outlet Syndrome and having my rib removed twice. He also guessed correctly that I had been diagnosed with temporomandibular joint dysfunction (TMJD) because of the facial pain and that I was having issues with my thyroid.

He remarked about my sweating, the swelling in some areas, and asked about my low-grade fevers, Horner syndrome and more. He discussed and noted the atrophy in my hands, arms, legs, feet, face, back and the dystonia in my hands and feet. By discussed, I mean he discussed it with the other doctors. Dr. Schwartzman hardly spoke to me.

Next, he had me do neurological tests. An easy one that you can do right now involves your hand. Take the tip of your index finger and tap it to the tip of your thumb as many times and as fast as you can. I thought that I did it very well, especially with my left hand. But Dr. Schwartzman explained the way I did it was awkward and slow, which was another symptom.

I did not understand, so he showed me. He could tap his fingers so fast that it looked like I was going in slow motion. Since then, when I ask others to do the same thing, I am amazed that I cannot go as fast, no matter how hard I try.

He watched me smile, had me stick my tongue out, and then asked if I had trouble swallowing and if my voice goes in and out sometimes. I said, "Yes, how did you know?" He said that the RSD was affecting my throat and intestines.

I had been diagnosed with gastrointestinal ischemia and gastroparesis a few years earlier. The hospitalist that performed the tests said there is a section of my intestines that was getting little to no blood. I did not understand how that was related to the RSD until I saw Dr. Schwartzman and learned that RSD causes vascular constriction, which can make it difficult to get an IV line inserted or even do blood tests.

I never realized that vascular constriction could also affect organs. I thought I was just eating too quickly or being lazy when I choked on food. I did not know why my voice changed or why I would lose it sometimes. The RSD even affected the way my nails and hair grow.

Dr. Schwartzman was spot on with everything. He added that whiplash or brachia plexus injuries are a leading cause of upper extremity RSD. Because of my additional traumas and surgeries, the RSD had spread.

Ketamine Infusions

Sometime near the end of the exam, Dr. Schwartzman said to the student doctors, “The only thing that will help this patient 100% is the coma treatment.”

I was shocked. I thought I was going to be getting outpatient ketamine infusions. I began to tear up. I kept telling myself not to cry. It is never good to cry at a doctor’s office. I wanted to be taken seriously and be strong. As soon as they left the room, tears flowed down my face. The nurse said she would be right back with all of the instructions and scripts that he was giving me.

I did not have any idea of the issues that were involved with RSD or that I had many of the symptoms. Instead of starting right away, I had to wait another 9 months to get a bed in the hospital, where I underwent 7 days of inpatient ICU ketamine infusions.

I went into the hospital in a wheelchair, but walked out on my own a week later, ready to live the next chapter in my life. That was Dec. 14, 2009. I still undergo ketamine infusion therapy about 4 times a year for booster treatments, but I am no longer on daily medications for pain.

I thank Dr. Schwartzman and all the research doctors out there coming up with treatments and scientific data for people like me with chronic rare diseases and severe life changing pain. We should always remember there is reason for hope. We just have to be active in seeking and using all of the resources available.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.  

Therapy Dogs Give Relief to Fibromyalgia Patients

By Pat Anson, PNN Editor

It’s well-known that having a pet or support animal can provide significant psychological benefits to people suffering from stress, anxiety or loneliness. A new study at the Mayo Clinic suggests that pet therapy can also help people with fibromyalgia.

To gain a better understanding of the physiological and emotional benefits of pet therapy, researchers monitored the hormones, heart rate, temperature and pain levels of 221 patients enrolled in the Mayo Clinic Fibromyalgia Treatment Program. Half of the participants spent 20 minutes interacting with a therapy dog and its handler, while the other half served as a control group, spending the same amount of time with the handler only.

The research findings, recently published in Mayo Clinic Proceedings, are striking. People who interacted with a therapy dog had a statistically significant increase in levels of salivary oxytocin – a hormone released by the pituitary gland that is known as the “cuddle hormone” or “love hormone.”

They were also more relaxed, their heart rates decreased, and they reported more positive feelings and fewer negative ones compared to the control group. Over 80% agreed or strongly agreed that animal therapy was helpful to them.  

Pain levels declined in both groups, but there was a larger decrease in those who interacted with the therapy dogs. On average, severe pain scores in that group dropped to more moderate levels.

“Given that individuals with FM (fibromyalgia) suffer pain chronically, this reduction, even if numerically minimal, could help to provide symptomatic relief and quality of life improvement,” researchers concluded. “Overall, the study showed that a 20-minute human-animal interaction (treatment group) as well as a human-human interaction (control group) could improve the emotional and physiological state of patients with FM; however, those who interacted with a therapy dog showed a more robust improvement.”

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Its cause is unknown and many treatments prove ineffective. 

Therapy Dogs Calmer

The Mayo Clinic study was unique in another way – because researchers monitored and collected saliva from the dogs to see how they responded to the therapy sessions. Although therapy dogs are used in a wide variety of clinical settings, little is known about the impact of therapy sessions on the emotional state of the dogs.

Researchers say the 19 dogs involved in the fibromyalgia study -- all members of the Mayo Clinic Caring Canines program – did not show signs of stress, appeared to be more relaxed, and had significantly lower heart rates at the end of the sessions, a sign that they enjoyed interacting with patients.

"We need to expand our understanding of how animal-assisted activity impacts therapy dog's well-being, and this sizeable study with 19 dogs of various breeds provided solid evidence that animal-assisted activity done in the right condition does not have negative impacts on well-trained therapy dogs," said François Martin, PhD, a researcher for Purina, which sponsored the study.

"This only encourages us to do more research to continue to demonstrate the power of the human-animal bond on people while ensuring assistance animals also experience positive wellness as a result of their work."

You don’t need a trained therapy dog to enjoy the benefits of having a pet. A recent survey of older adults found that dogs, cats and other pets help their owners enjoy life, reduce stress, keep them physically active, and take their minds off pain.

How Ketamine Infusions Helped Me

By Madora Pennington, PNN Columnist

Berkley Jones is a tough lady. Already a nurse, she joined the U.S. Air Force in her late 30’s, even though she had never run a mile in her life. She worked hard, made it through boot camp and went directly into officer training.

Her life changed after an allergic reaction so severe it required hospitalization. Berkeley never felt the same. Aching and tired, an immunologist diagnosed her with fibromyalgia. Berkley powered on.

Then, during a training exercise that simulated medical scenarios that might happen from a nuclear attack, she severely injured her arm. She awoke after surgery with her arm swollen to five times its normal size and feeling like it was on fire. The pain was unbearable. This was the beginning of her life with Complex Regional Pain Syndrome (CRPS).

For the next six years, her life was consumed by pain. Berkley tried everything doctors recommended. Nothing eased her agony. Wheelchair-bound, she left the military. “I basically stayed in bed most of the time. I was very depressed and in pain,” she recalls.

Berkley heard of ketamine from a friend, looked around and was accepted into a ketamine for CRPS study. She checked into the hospital for 5 days of intravenous ketamine infusions. The results were life-changing.

“By the end of the study I was able to use a cane instead of a wheelchair. I was able to get out of bed and my pain was down to livable levels,” she says.

Berkley went on to write a book, “Ketamine Infusions: A Patient's Guide” and organized Facebook groups to educate patients and doctors about ketamine.

From Anesthetic to Party Drug

Ketamine has become a trendy new treatment for pain and depression, but it’s actually been around for decades. Chemists first discovered ketamine in 1956. By the 1960s, it was in widespread use as an anesthetic, from veterinary offices to battlefields. Ketamine is only approved by the FDA for depression, anesthesia and post-surgical acute pain — which makes its use as a treatment for chronic pain off-label.

Ketamine is not an opioid and does not suppress breathing, making it relatively safe to use. But it does produce an unusual state of dissociation. Patients appear awake, but are often unable to respond to sensory input.

Because the experience is similar to psychosis (delirium, delusions or hallucinations), ketamine also became an underground party drug.

More and more uses are being found for this very unique compound. Ketamine triggers production of glutamate in the brain, which makes connections in the brain regrow. Cognition and mood improve as the brain gets a reboot from the damage of long-term stress that leads to excessive negative thoughts and feelings.

For chronic pain sufferers, ketamine temporarily reverses “central sensitization,” where the brain and spinal nerves receive so much pain input, they go off kilter and the slightest touch becomes painful. This can get so bad that some chronic pain sufferers come to find odors, light and sound extremely painful. Brain fog, poor memory, poor concentration and intense anxiety also happen as part of this cycle of pain overload.

Low Dose Ketamine

While hospitals treat chronic pain patients with multi-day, high dose infusions of ketamine, outpatient clinics have sprouted up around the country, offering less intense treatment with lower doses.

I began seeing anesthesiologist Dr. David Mahjoubi, of Ketamine Healing Clinic of Los Angeles this year. My foot was very swollen, weeks after surgery. I was looking for a way to reduce the inflammation without stopping the healing process, as ice, NSAIDs and steroids tend to do. I was fortunate to get an appointment, as some LA clinics have a two-year waiting list for infusions.

Dr. Mahjoubi explained ketamine to me this way: “It increases connections between brain cells, thus ‘rewiring’ brain circuitry. Ketamine also blocks pain receptors called NMDA. This is the mechanism for blocking pain. For persons with PTSD, the trauma seems to get processed in a mild, non-troubling way. Ketamine separates one from their anxiety or depression. A ‘release’ is how patients commonly describe it.”

In Dr. Mahjoubi’s experience, ketamine infusions multiple days in a row can be a bit tough. Spreading them out over several weeks can still get good results. It depends on the individual and the amount of relief they receive.

I was afraid to try ketamine, but agreed to a low dose, one-hour infusion. The swelling in my foot dramatically improved. Chronic, low-grade discomfort along my spine also disappeared. I felt emotional relief from past trauma, from pain and other life experiences.  

I continued with one low dose infusion every few weeks. I don’t like the experience of the infusion, but it has been well worth it.

I was relieved of minor aches and able to increase my exercise. I did not feel terror when pain kicked in. Sometimes the pain just floated away.

I no longer feared my physical therapist touching my neck, and noticed I was enjoying it. My mood improved and I felt smarter. My ability to concentrate and remember improved. 

My neighbor’s annoying dog sounded like he was a few houses away, not barking inside my head.

MADORA PENNINGTON GETTING AN INFUSION

I felt more connected with others and more accepting of life — less anxious, less terrorized, less inclined to ruminate after every infusion.

I do tend to have fatigue or short periods of intense emotion, which is not unusual. For me, this is just hard work on my health, like going to physical therapy.

Treatment for Depression

Tara Dillon, a nurse practitioner, opened Happier You, a ketamine clinic in Columbus, Ohio, after infusions helped her 20-year struggle with depression. She’s had good results treating patients with psychiatric complaints, such as depression, anxiety, and bipolar disorder.

“It's well-known that pain and psychiatric diagnoses, particularly depression, tend to coincide. Patients often report physical improvements such as relief from IBS, improved sleep, or increased energy after ketamine therapy,” she explained. “While everyone is nervous for the first infusion, since they don't know what to expect, most patients end up enjoying the experience.”

Tara usually starts with a low dose of 0.5mg ketamine over 40 minutes, but will titrate up depending on how a patient responds. The most common side effect is mild nausea. Ketamine is not a cure for chronic pain, and it takes time to have an effect.

“For me, ketamine never kicks in immediately. Some people get relief in the first week. It takes at least two weeks and for some, like me, it can take 3 to 4 weeks,” says Berkley Jones. “Once it does kick in, I usually have low pain levels for about 6 to 8 weeks and then they start to climb again. Sometimes overnight the pain comes back excruciating, but the majority of the time it’s a slow increase in my pain back to where it was.” 

Unfortunately, insurance won’t always cover ketamine. While the drug itself is cheap, the infusions are expensive because patients must be monitored. That is a real shame, as high-impact chronic pain affects 20 million adults in the United States. This is terrible burden not only to the sufferer, but to their loved ones and the community. Perhaps this will change if and when ketamine is FDA approved as a treatment for chronic pain.

Madora Pennington lives with Ehlers-Danlos Syndrome. Sher writes about EDS and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

Becoming Aware of Ingrained Thoughts Can Reduce Pain and Anxiety

By Dr. David Hanscom, PNN Columnist

Self-awareness is the essence of healing. You cannot stimulate your brain to develop in a given direction unless you become aware of who you are and where you are starting from. Awareness is a meditative tool that can be used to calm the nervous system, reduce chronic pain and anxiety, and move forward with your life.

There are four patterns of awareness that I’ve written about in previous columns that work for me:

Environmental awareness is placing your attention on a single sensation – taste, touch, sound, temperature, etc. What you are doing is switching sensory input from racing thoughts about pain to another sensation. This is the basis of mindfulness – fully experiencing what you are doing in the moment.

I use an abbreviated version that I call “active meditation,” which is placing my attention on a specific sensory input for 5 to 10 seconds. It is simple and can be done multiple times per day.  

Emotional awareness is more challenging. It often works for a while, but then it doesn’t. When you are suppressing feelings of anxiety, your body’s chemistry is still off and full of stress hormones. This translates into pain and other physical symptoms.

Allowing yourself to feel all of your emotions is the first step in healing because you can’t change what you can’t feel. Everyone that is alive has anxiety. It is how we survive.

Judgment awareness is a major contributor to the mental chaos in our lives. You create a “story” or a judgment about yourself, another person or situation that tends to critical and inflexible.

Dr. David Burns in his book “Feeling Good” outlines 10 cognitive distortions that are a core part of our upbringing. They include:

• Labeling yourself or others

• “Should” thinking – the essence of perfectionism

• Focusing on the negative

• Minimizing the positive

• Catastrophizing

These ingrained thoughts are the fourth and most problematic to be aware of. You cannot see or correct them without actively seeking them out.

Our Brains Are Programmed at an Early Age

Our family interactions in childhood are at the root of how we act as adults. They stem from our upbringing and the fact that our brains are “hard-wired” during our formative years. We know from recent neuroscience research that concepts and attitudes from childhood are embedded in our brains as concretely as our perception of a chair or table.  

I used to say that thoughts are real because they cause neurochemical responses in your body. But they are not reality. I was wrong.  

It turns out that your thoughts and ideals are your version of reality. Your current life outlook continues to evolve along the lines of your early programming or “filter.” It is why we become so attached to our politics, religion, belief systems, etc. It is also the reason that humans treat each other so badly based on labels.  

One example, amongst an endless list, was how we locked up “communists” during the McCarthy era of the 1950’s and 1960’s. It is also why so many minority groups are persecuted and often treat each other badly. 

It is critical to understand that these are attitudes and behaviors that you cannot see because they are inherent to who you are. It is also maybe the greatest obstacle to people getting along. We are hard-wired enough that we don’t recognize or feel these patterns -- it’s just what we do. It’s behavior that sits under many layers of defenses and has to be dug out by each person.  

Our family-influenced habits and actions are much more obvious to our spouses and immediate family than they are to us. We can only get in touch with them through counseling, seminars, psychotherapy, self-reflection, spousal feedback, etc. What you are not aware of can and will control you.  

Slowing Down 

Here is an example of awareness I learned at work. A few years ago, before I retired as a spine surgeon, I became aware that I consistently started to speed up towards the end of each surgery. I also realized that over the years, probably 80% of my dural tears (the envelope of spinal tissue containing the nerves and cerebrospinal fluid) occurred in the last 30 minutes of a long surgery.  

The fatigue factor was part of the problem, but speed was more critical. I still didn’t notice that I was speeding up. I needed feedback from my partners or assistants, so I asked them to act as my coaches. I’d stop for a few seconds and say, “The difficult part of this case is done. It would be easy for me to relax and hurry to finish. Please speak up if you see me starting to rush.”  

Every move in spine surgery is critical, so I had to make the choice to consciously slow down. The end of each surgery is just as important as the beginning and middle. My complication rate dropped dramatically when I became more aware of what I was doing. 

This is a brief overview of how awareness plays a role in successfully navigating daily life. It’s something of a paradox, because when we are truly immersed in the moment there are no levels of awareness. It’s just complete “engagement-in-the-present-moment” awareness.

There are many layers to this discussion, but I hope this is a good starting point for you to understand the importance of mindful awareness.  

Dr. David Hanscom is a retired spinal surgeon. He recently launched a new website – The DOC Journey – to share his own experience with chronic pain and to offer a pathway out of mental and physical pain through mindful awareness and meditation.

Guideline Recommends Topical Pain Relievers for Muscle Aches and Joint Sprains

By Pat Anson, PNN Editor

A new guideline for primary care physicians recommends against the use of opioid medication in treating short-term, acute pain caused by muscle aches, joint sprains and other musculoskeletal injuries that don’t involve the lower back.

The joint guideline by the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) – which collectively represent nearly 300,000 doctors in the U.S. – recommends using topical pain creams and gels containing non-steroidal anti-inflammatory drugs (NSAIDs) as first line therapy. Other recommended treatments include oral NSAIDs, acetaminophen, specific acupressure, or transcutaneous nerve stimulation (TENS).

Musculoskeletal injuries, such as ankle, neck and knee injuries, are usually treated in outpatient settings. In 2010, they accounted for over 65 million healthcare visits in the U.S., with the annual cost of treating them estimated at over $176 billion.

"As a physician, these types of injuries and associated pain are common, and we need to address them with the best treatments available for the patient. The evidence shows that there are quality treatments available for pain caused by acute musculoskeletal injuries that do not include the use of opioids," said Jacqueline Fincher, MD, president of ACP.

Opioids, including tramadol, are only recommended in cases of severe injury or intolerance to first-line therapies. While effective in treating pain, the guideline warns that a “substantial proportion” of patients given opioids for acute pain wind up taking them long-term.   

The new guideline, published in the Annals of Internal Medicine, recommends topical NSAIDs, with or without menthol, as the first-line therapy for acute pain from non-low back, musculoskeletal injuries. Topical NSAIDs were rated the most effective for pain reduction, physical function, treatment satisfaction and symptom relief.

Treatments found to be ineffective for acute musculoskeletal pain include ultrasound therapy, non-specific acupressure, exercise and laser therapy.

"This guideline is not intended to provide a one-size-fits-all approach to managing non-low back pain," said Gary LeRoy, MD, president of AAFP. "Our main objective was to provide a sound and transparent framework to guide family physicians in shared decision making with patients."

Guideline Based on Canadian Research

Interestingly, the guideline for American doctors is based on reviews of over 200 clinical studies by Canadian researchers at McMaster University in Ontario, who developed Canada’s opioid prescribing guideline. The Canadian guideline, which recommends against the use of opioids as a first-line treatment, is modeled after the CDC’s controversial 2016 opioid guideline.  

After reviewing data from over 13 million U.S. insurance claims, McMaster researchers estimated the risk of prolonged opioid use after a prescription for acute pain was 27% for “high risk” patients and 6% for the general population.

"Opioids are frequently prescribed for acute musculoskeletal injuries and may result in long-term use and consequent harms," said John Riva, a doctor of chiropractic and assistant clinical professor in the Department of Family Medicine at McMaster. "Potentially important targets to reduce rates of persistent opioid use are avoiding prescribing opioids for these types of injuries to patients with past or current substance use disorder and, when prescribed, restricting duration to seven days or less and to lower doses."

Riva and his colleagues said patients are also at higher risk of long-term use if they have a history of sleep disorders, suicide attempts or self-injury, lower socioeconomic status, higher household income, rural residency, lower education level, disability, being injured in a motor vehicle accident, and being a Medicaid recipient.

A history of alcohol abuse, psychosis, episodic mood disorders, obesity, and not working full-time “were consistently not associated with prolonged opioid use.”

The McMaster research, also published in the Annals of Internal Medicine, was funded by the National Safety Council (NSC), a non-profit advocacy group in the U.S. supported by major corporations and insurers. The NSC has long argued against the use of opioid pain relievers, saying they “do not kill pain, they kill people.”

Finding Pain Relief in a Virtual World

By Madora Pennington, PNN Columnist

I am sitting on a deserted beach in Tasmania, listening to the gently lapping waves. All my worries fade in just 3 minutes.

While on my couch, I am touring the famous sites of London. Have I been on vacation? I feel as if I have.

I am by a creek in Bavaria. Water gently crashes against the rocks. Leaves fall to the ground. In four minutes, I am in state of joy.

Underwater with a school of dolphins, twisting my head to get the best views as they swim above me and all around, I forget anything that bothers me, physical or mental.

How can I be in so many places? I am using a virtual reality program designed to relieve chronic pain. I love it. I look forward to doing it every day.

Later, when I am out and about, a sound I heard during my VR sessions, perhaps the swaying of a tree, makes my body relax without effort.

The AppliedVR headset I am using looks like a blacked-out snorkeling mask. It came with a warning not to expose it to direct sunlight, and to take great care not to scratch the lenses. The company loaned me the device to try at no cost and with no stipulations for this review.

Virtual reality (VR) had its start as entertainment in video gaming. Headsets have speakers or earphones, and are usually connected to a joystick or hand controller. When the user moves their head, tracking software shifts the images, providing an immersive experience into a full 360-degree view of a 3D world.

Besides gaming, VR has a growing number of practical uses. VR technology is used to teach dangerous jobs like piloting or to give doctors simulated practice at surgery. The U.S. military uses VR to train soldiers to fight and build mental resilience for battle. Ford employees use VR to inspect and look for problems in virtual automobiles before they are even manufactured. Architects and engineers use it to evaluate and find problems in their design work.

In a medical setting, VR therapy was first used in caring for patients who suffered burn wounds, which can be so painful that even opioids can be insufficient. A study found that VR, when coupled with pain medication, provided burn patients with significant relief.

More Than Just Distraction

How does VR make such a difference in pain?

“The most acceptable theory is the Gate theory of attention. It postulates that VR reduces the perception of pain by absorbing and diverting attention away from pain,” says Dr. Medhat Mikhael, a pain management specialist.

But there’s more to it. Dr. Brennan Spiegel, director of Cedars-Sinai's Health Service Research, completed a VR study on 120 hospitalized patients in 2019, which showed that VR significantly reduces pain. It was most effective for severe pain.

“Virtual reality is a mind-body treatment that is based in real science. It does more than just distract the mind from pain, but also helps to block pain signals from reaching the brain, offering a drug-free supplement to traditional pain management," Spiegel said.

Short-term, acute pain is a different beast than chronic pain. Only a few studies have been done using VR to treat chronic pain, which can overwhelm the nervous system, making the body even more sensitive to and aware of pain. This cycle can become so entrenched it can cause the body to interpret benign stimuli, such as the light brush of fabric against skin, as painful.

Early studies on VR for chronic pain are promising. In a study published in 2016, chronic pain patients had an average 60% reduction in pain from VR treatment. A third of the participants experienced total pain relief while doing VR sessions. They had a wide variety of conditions, such as spine pain, hip pain, myalgia, connective tissue disease, interstitial cystitis, chest pain, shoulder pain, abdominal pain and neuropathy. 

Another study recently found that VR reduces pain and improves mood and sleep in people living with fibromyalgia or chronic lower back pain.  

Pain Drifts Away

I’ve had a lifetime of chronic pain from the collagen disease, Ehlers-Danlos Syndrome. My body is very weak and flimsy. Having chronic pain and disability sometimes makes me feel resentful and betrayed by my own body.

In one VR session, I stare into the heavens. I am shown a projection of a human body and nervous system. A kind, encouraging woman explains simply and compassionately the phenomenon of pain. I hate my body less in two minutes.

Ordinarily, I would never play a video game. I don’t like cartoons. Meditating makes me anxious. I find it difficult to even lose myself watching a movie. I would not have thought I would respond well to virtual reality. But from the first brief session, I did.

I learned how to calm and balance my nervous system in an animated forest. Gently encouraged to breathe in time with a giant whimsical tree, the ground and surrounding plants change, becoming ever more colorful each time I exhale. The loving woman tells me I have changed myself and the outside world. I have to agree.

Some sessions are games that teach me to redirect my attention away from pain. In a cartoon winter wonderland, I shoot snowballs at happy teddy bears, who giggle when I hit them. I have made the teddy bears and myself happy.

In others programs, I swim with jellyfish. Or sunbathe on a beach in Australia. Or sit by a stream in the snowfall. You can watch a sample of these programs below.

The benefits of VR therapy continued for me after the sessions ended. When pain or panic about pain began to set in, I found it drifts away rather than latching onto me like it used to.

After a couple weeks of VR, during a visit to physical therapist, I noticed I was no longer afraid of her touching my neck and back, and actually enjoyed it.

VR reminds me of times in my life when I was fully engaged in the moment and overwhelmed by wonder or beauty. As a child swimming in the ocean, once I was surrounded by dolphins. They clicked and called to each other. I immediately forgot how cold I was and how my wet-suit was cutting off the circulation in my hands.

VR took me back to other transcendent moments of my life, like playing in an orchestra, surrounded by instruments producing layers of organized sound. Standing in front of Van Gogh’s Bedroom. A ride at Disneyland. Falling in love.

My only criticism of VR is the weight of the headset. The device is heavy and could be difficult for someone with neck or head pain to tolerate.

AppliedVR’s technology is being used in hundreds of hospitals, but it is not yet available for home use. The company hopes for a broader launch in 2021, but getting insurance coverage will be key.

"We know that living with and managing chronic pain can be a debilitating and costly challenge that is only exacerbated by the COVID crisis.  As such, we are focused on achieving our vision of delivering safe and effective VR therapeutics into the home where the need for non-opioid chronic pain treatment options is greatest,” says AppliedVR CEO Matthew Stoudt.

“We are now focused on partnering with payers to demonstrate how our chronic pain VR therapeutic improves health outcomes, reduces costs and empowers patients to lead their best lives.  This is the key to making VR a reimbursable standard of care for pain management."

In addition to pain, VR therapy is also being used to relax people going through dental procedures, chemotherapy, physical rehabilitation, phobias, anxiety and post-traumatic stress disorder (PTSD).

You cannot talk your brain out of perceiving pain, but with VR it finds other, better things to do than just focus on pain. Cognitive behavioral therapy and self-soothing techniques do that too, but VR disengaged my brain from the pain perception cycle at a much deeper level, just as pain once hijacked my thoughts and attention.

Madora Pennington writes about Ehlers-Danlos Syndrome and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

FDA Approves Capsaicin Patch as Treatment for Diabetic Neuropathy

By Pat Anson, PNN Editor

Millions of patients with diabetic peripheral neuropathy live with burning or stinging pain in their hands and feet. In what could be called a case of fighting fire with fire, the U.S. Food and Drug Administration has approved the first use of a medicated patch made with capsaicin – the spicy substance that makes chili peppers hot – as a treatment for diabetic neuropathy.

The Qutenza skin patch is made by Grünenthal and contains 8% capsaicin, which acts on pain receptors in the skin by desensitizing and numbing nerve endings.

“Pain associated with diabetic neuropathy is an extremely challenging condition to diagnose, treat and manage effectively, which has a significant quality of life impact for many patients,” said David Simpson, MD, a Professor of Neurology at the Icahn School of Medicine. “In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments.”

A 2015 study found that Qutenza worked faster than pregabalin (Lyrica) in treating neuropathic pain, providing relief in 7.5 days, compared to an average of 36 days in patients taking pregabalin. Patients who used Qutenza were also more satisfied with their treatment and had fewer side effects.

That same year the European Commission approved Qutenza as a treatment for diabetic neuropathy, but it took another five years for the FDA to give its approval for the same condition. The patch was initially approved by the FDA in 2009 for treating post-herpetic neuralgia, a complication from shingles.

“Painful diabetic peripheral neuropathy has a significant impact on the day-to-day lives of millions of individuals, and we believe Qutenza can be a much-needed non-opioid treatment option for these patients,” Jan Adams, Grünenthal’s Chief Scientific Officer, said in a statement. “This expanded indication of Qutenza in the U.S. is an exciting milestone in our efforts to make Qutenza available to even more patients in need worldwide.”  

A big catch is that the patch shouldn’t be applied at home and should only be used sparingly. According to its warning label, Qutenza should be applied by a doctor or healthcare professional, who should be wearing a face mask and gloves to protect themselves in a well-ventilated area. Up to four patches can be applied on the feet for up to 30 minutes, a procedure that can be repeated every three months. The most common side effects are redness, itching and irritation of the skin where the patch is applied.

Qutenza has gotten mixed reviews from patients, who warned that capsaicin can cause painful burning sensations.

“Qutenza really does work. I did have very intense burning,” a patient posted in a review on Drugs.com. “The pain can be mind blowing but it does subside and a cool fan helps. Don't let your pets near the area as it will burn them. I have had multiple Qutenza and… it lasts up to 3 months plus. Don't apply yourselves. Use a health professional as it does burn.”

“Although I was informed about this treatment and how your body might react to it, my case spiraled out of hands,” another patient wrote. “The medics had to call a team to manage my situation. The pain was so much that without a shred of doubt words simply can not explain.”

Diabetic neuropathy is a progressive and debilitating complication of diabetes that affects more than 5 million Americans. Patients typically experience numbness, tingling or stabbing sensations in their hands and feet. More severe cases can result in foot ulcers, amputations and other complications.

Good Attitude Improves Effectiveness of Yoga and Physical Therapy

By Pat Anson, PNN Editor

Yoga is a four-letter word for a lot of chronic pain patients, who are often urged to try yoga or physical therapy to ease their pain. Many pain sufferers believe exercise will only make their pain worse.

But a new study by researchers at Boston Medical University found that people with chronic lower back pain are more likely to benefit from yoga and physical therapy if they have a positive attitude about exercise.

The study involved 299 mostly low-income patients with chronic lower back pain who took weekly yoga classes or had physical therapy for 12 weeks. They were compared to a control group who had “self-care” – which consisted of reading a handbook on self-management strategies for back pain, such as stretching and strengthening exercises.

Nearly half (42%) of those who had yoga or physical therapy responded to the treatment, while only 23% of those in the self-care group had improvement in their pain and physical function.

Interestingly, participants who continued taking pain medication during the study were more likely to benefit from yoga (42%) than those who had physical therapy (34%) or self-care (11%).

"Adults living with chronic low back pain could benefit from a multi-disciplinary approach to treatment including yoga or physical therapy, especially when they are already using pain medication,' said lead author Eric Roseen, DC, a chiropractic physician at Boston Medical Center.

Another important finding from the study, which was published in the journal Pain Medicine, is the effect that “fear avoidance” can have on patient outcomes.

Among the participants who had less fear of exercise, 53 percent responded to yoga, 42 percent responded to physical therapy and 13 percent responded to self-care. In contrast, participants who had a high fear of exercise usually had a poor response, regardless of what therapy group they were in.  

Other factors that appeared to improve patient response were a high school education, higher income, employment and being a non-smoker.

"Focusing on a diverse population with an average income well below the U.S. median, this research adds important data for an understudied and often underserved population," said Roseen. "Our findings of predictors are consistent with existing research, also showing that lower socioeconomic status, multiple comorbidities, depression, and smoking are all associated with poor response to treatment."

It doesn’t take a lot of time to benefit from exercise. A 2017 study found that just 45 minutes of moderate physical activity a week improved pain and function in patients with osteoarthritis.

A few weeks of yoga significantly improved the health and mental well-being of people suffering from arthritis, according to a 2015 study at Johns Hopkins University.

Virtual Reality Therapy Can Reduce Chronic Pain at Home

By Pat Anson, PNN Editor

Therapeutic virtual reality (VR) can reduce chronic pain, improve mood and help people sleep, according to a small study of 74 patients living with fibromyalgia or chronic lower back pain.

The research, published online in JMIR-FR, is one of the first to look at the effectiveness of VR therapy when self-administered at home by chronic pain patients. It was funded by AppliedVR , a Los Angeles based company that is developing therapeutic VR content to help treat pain, depression, anxiety and other conditions.

“People with chronic pain often have limited access to comprehensive pain care that includes skills-based behavioral medicine. We tested whether VR that was self-administered at home would be an effective therapy for chronic pain,” said Beth Darnall, PhD, a pain psychologist who is AppliedVR’s chief scientific advisor.

“We found high engagement and satisfaction, combined with clinically significant reductions in pain and low levels of adverse effects, support the feasibility and acceptability for at-home, skills-based VR for chronic pain.”

Participants in the study were given VR headsets and instructed to have at least one session daily for 21 days. Half of the patients listened to audio-only programming, while the other half watched “virtual” programs in which they could swim with dolphins, play games or immerse themselves in beautiful scenery.

The programs are designed to help patients learn how to manage their pain and other symptoms by using cognitive behavioral therapy (CBT) to distract them and make their pain seem less important.

A sample of what they saw can be seen in this video:  

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy, which worked significantly better than the audio-only format in reducing five key pain indicators:

• Pain intensity reduced an average of 30%

• Physical activity improved 37%

• Mood improved 50%

• Sleep improved 40%

• Stress reduced 49%

Previous VR studies have had similar findings, but have largely focused on patients in hospitals and clinical settings. 

“This study is a fundamental step for advancing a clinically proven, noninvasive and safe digital therapeutic like VR for chronic pain, and demonstrates our platform is both viable and efficacious,” said Josh Sackman, co-founder and president of AppliedVR.

“Living with and managing chronic pain daily can be a debilitating and costly challenge, and many patients suffering from it can feel hopeless and desperate for any relief. So, as we engage in and accelerate more in-depth clinical research, we want them to know that we’re committed to making VR a reimbursable standard of care for pain.”

AppliedVR products are being used in hundreds of hospitals, but are currently only available to healthcare providers. The company recently partnered with University of California at San Francisco to study how VR therapy can improve patient care for underserved populations.

AppliedVR is also conducting two clinical trials to see if VR therapy can reduce the use of opioid medication for acute and chronic pain. The National Institute on Drug Abuse recently awarded nearly $3 million in grants to fund the trials.

The company is currently recruiting patients with chronic lower back pain for an 8-week trial of VR therapy. Headsets and other material will be mailed at no cost to participants at their homes. No in-person visits are required.  

VA Studying Laughing Gas as Treatment for Veterans With PTSD

By Pat Anson, PNN Editor

The U.S. Department of Veterans Affairs is sponsoring a small study to see if nitrous oxide – commonly known as laughing gas – could be used as a treatment for veterans suffering from post-traumatic stress disorder (PTSD), pain and depression.

The placebo-controlled Phase 2 study will be held at the VA Palo Alto Health Care System in California this fall. Investigators plan to recruit 104 veterans with PTSD to participate. Half would inhale a gaseous mix of nitrous oxide and oxygen, while the other half would be given a placebo.

Although PTSD is the primary focus of the study, researchers also hope to learn if nitrous oxide could be used to treat pain and other symptoms.

“Specifically, the investigators will first assess whether nitrous oxide treatment improves PTSD symptoms within 1 week. In parallel, the investigators will explore whether the treatment improves co-existing depression and pain,” researchers said. “In addition, the investigators will explore nitrous oxide's effects on a PTSD-associated impairment that is often overlooked - disruption in cognitive control, a core neurobiological process critical for regulating thoughts and for successful daily functioning.”

Military veterans suffering from PTSD often experience pain, anxiety, anger and depression. About one in five veterans who served in the Iraq or Afghanistan wars developed PTSD within a year of coming home.

In a small pilot study funded by the VA, three veterans with PTSD inhaled a single one-hour dose of nitrous oxide through a face mask. Within hours, two of the patients reported a marked improvement in their symptoms. The improvement lasted one week for one patient, while the second patient's symptoms gradually returned over the week. The third patient reported an improvement two hours after his treatment, but his symptoms returned the next day.

"While small in scale, this study shows the early promise of using nitrous oxide to quickly relieve symptoms of PTSD," said anesthesiologist Peter Nagele, MD, chair of the Department of Anesthesia & Critical Care at University of Chicago Medicine and co-author of a study recently published in the Journal of Clinical Psychiatry.

Nitrous oxide is a colorless and odorless gas that is commonly used by dentists to manage pain and anxiety in patients. It was once widely used in American hospitals to relieve labor pain, but fell out of favor as more Caesarean sections were performed and women opted for epidural injections and spinal blocks.

Some hospitals are now reintroducing nitrous oxide as a safer and less invasive option. The gas makes patients less aware of their pain, but does not completely eliminate it.  Recent studies have shown that about 70% of women who receive nitrous oxide during labor wind up using another analgesic due to inadequate pain relief.

"Like many other treatments, nitrous oxide appears to be effective for some patients but not for others," explained Nagele. "Often drugs work only on a subset of patients, while others do not respond. It's our role to determine who may benefit from this treatment, and who won't."

If findings from the VA’s pilot study are replicated in further research, it may be feasible to use nitrous oxide for rapid relief from PTSD, while longer-term treatments like psychotherapy and pharmaceutical drugs are also implemented.

FTC Takes Dim View of Light Therapy Device

By Pat Anson, PNN Editor

Low level light therapy (LLLT) – also known as “laser therapy” – has been touted for years as a treatment for arthritis, neck and back pain, fibromyalgia, neuropathy and even spinal cord injuries.

But in the first case of its kind, the Federal Trade Commission is going to court to get the makers of a light therapy device called the Willow Curve to stop making deceptive claims that it can treat chronic pain.

“When LLLT sellers say their devices will relieve pain, they’d better have the scientific proof to back it up,” Andrew Smith, Director of the FTC’s Bureau of Consumer Protection, said in a statement. “People looking for drug-free pain relief deserve truthful information about these products.”

In a complaint filed in federal court against the inventors and marketers of the Willow Curve, the FTC alleges that Dr. Ronald Shapiro and David Sutton “personally made deceptive claims about the health benefits” of the device and falsely claimed it was approved by the Food and Drug Administration to treat chronic pain, severe pain and inflammation.

Willow Curve is a curved plastic device that delivers low-level light and mild heat to painful areas. It’s been sold online and through retailers and healthcare professionals since 2014, most recently at a price of $799.

In a 2016 commercial, television personality Chuck Woolery said the Willow Curve offers “drug free pain relief for the digital age” and personally promised that “the Curve could change your life.”

Other advertisements tout Willow Curve as “clinically proven” and the “world’s first digital biosensory, biotherapeutic laser smart device” — even though there is no scientific evidence to support those claims, according to the FTC complaint.

The FTC also alleges that Shapiro and Sutton deceptively claimed Willow Curve comes with a “risk free money back” guarantee. In reality, consumers who returned the device had to pay shipping and handling costs, and often did not receive a refund at all or had to wait more than a year to get their money back.

The settlement imposes a $22 million judgment against the defendants, which will be partially suspended if Shapiro and Sutton each pay $200,000. It also asks the judge to issue a permanent injunction to prevent future false advertising of the Willow Curve. The complaint was filed in the U.S. District Court for the Eastern District of Michigan.

What Pain Rules Are You Following?

By Ann Marie Gaudon, PNN Columnist

As part of his pioneering work on behavioural analysis, psychologist B.F. Skinner coined the term “rule-governed behaviour” in 1966.

We all live by rule-governed behaviours, they’re part of our learned history. For example, a young child can be told “never touch a hot stove” and they will not. Most people don’t need to suffer the consequence of being burned by a hot stove because we are able to learn the lesson from our language abilities.

Other rules may include judgments about ourselves, our environment and about others, which can lead to behaviours that make our lives more -- or less -- enjoyable.

When living with chronic pain, our minds give us no shortage of rules. Creating rules about pain is one way that our minds process and react to it. Why? It’s because our minds are always trying to protect us, to keep us safe, alive and as pain-free as possible..

However, the mind doesn’t discriminate and can be maladaptive. Some rules will be very helpful (“I must avoid certain foods due to colitis”) and some will be completely arbitrary and unhelpful (“I must avoid all types of exercise because of a torn rotator cuff”).

The problem with buying into some rules, or treating them as if they were the literal truth, is that we find ourselves going over the same self-defeating tracks over and over again. One simple sentence can take on colossal dimensions.

“Beth” will be our pain patient of the day. She has a torn rotator cuff and has taken on the sole identity of “chronic pain patient” to the exclusion of all other roles in her life. It’s become a real problem. Take a look at the rules Beth has developed for herself due to chronic pain:

“I can’t work if I’m in pain.”

“Feeling pain is unacceptable. I can’t live a good life with that feeling.”

“It simply isn’t fair that I should suffer with this.”

“Exercising will make the pain worse.”

As a result of Beth buying into these rules, what do you think her life has become? If you think that Beth has locked herself up tightly in a “pain chain,” then you are correct. Her suffering has gotten worse from this type of “dirty pain.”

You may have noticed that some of Beth’s rules are patently absurd. There is no fault to be found here. Our minds are rule makers and problem-solving machines – even when the problem is thus far unsolvable (chronic pain). Beth is not yet aware of how her mind’s reactions to her pain are choking off her life, and not yet aware that there are strategies to help her free herself.

As a professional therapist, I would not be telling Beth her rules are true or false, and I would encourage her to do the same. That self-argument would be unproductive: “I am unlovable”…”Yes I am lovable”… “No I am not”… and so on.

A debate like that is not helpful. Instead, I would be asking Beth questions in an attempt to put some metaphorical space between her and her maladaptive rules. You can ask yourself these same questions about your own limiting rules.

Can you identify your overall pain rule and can you name it? Nothing can be done about these restrictions until you become aware of them and can identify them yourself.

Do you notice what happens when you follow this rule? It is highly likely that when you follow the rule your anxiety and distress will go down in the short-term. However, in the long-term, your behaviour will become more and more rigid. You will have much less choice in your life and move far away from a life that you value. Relationships with yourself and others will pay a high price. Your suffering will increase exponentially.

Can you look at this rule in terms of workability? If you continue to follow this rule, is this a workable solution to your suffering? Will this be helpful to you to live a richer, more meaningful life? Are the long-term costs worth the short-term payoff?

Are you prepared to make a choice?  You cannot stop the rule from popping into your mind, but you do have a say in how you respond. Will you follow this rule or choose to do something different? Will you bend or change the rule? Will you be flexible?

Do you notice what happens with your choice? If you choose to follow the rule, where does that take you? If you choose something different, where does that lead to?

This type of self-exploration would be a first step in addressing Beth’s restrictive rules and the consequences of blindly following them. Learning to choose new rules to influence her behaviour is akin to laying down new tracks over the old detrimental ones.

Beth will do well to acquire all of the tools she can to help her to live a better life, alongside the challenges she faces from chronic pain. Psychotherapy is one of those tools.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website. 

New Treatment Significantly Reduces ‘Frozen Shoulder’ Pain

By Pat Anson, PNN Editor

Preliminary results from a small study show that an experimental treatment for adhesive capsulitis -- also known as “frozen shoulder” – dramatically reduces pain and quickly improves function in patients.

Frozen shoulder occurs when ligaments and connective tissues surrounding the shoulder joint become sore and inflamed. The inflammation gets so painful that many patients have difficulty using their arms. The resulting lack of use makes the shoulder joint even more stiff and inflamed – a vicious cycle that “freezes” the shoulder in place.

About 200,000 people annually in the U.S. develop frozen shoulder, mostly middle-aged adults. Several years ago, I was one of them. The pain was so bad at times, it felt like someone whacked me in the the shoulder with a baseball bat. I had trouble putting on a shirt or sleeping in the same position for more than a few hours.

Frozen shoulder is usually treated with physical therapy, massage, joint injections or pain medication, until the symptoms resolve in a few months or perhaps even years. Thankfully, that’s what happened to me. More serious cases can result in rotator cuff surgery.  

Researchers at the Vascular Institute of Virginia used a less invasive procedure called Arterial Embolization of the Shoulder (AES) to reduce blood flow into the shoulder of 16 patients with adhesive capsulitis. Physicians inserted a catheter through a pinhole-sized incision in the patients' wrists that was used to feed microscopic particles into six arteries leading into the shoulder.

"Patients with frozen shoulder are essentially told to tough it out until their symptoms improve, but considering the significant pain and decreased function many experience, we looked to determine if this treatment model of embolization, already in use in other areas of the body, could provide immediate and durable relief," said lead author Sandeep Bagla, MD, director of interventional radiology at the Vascular Institute of Virginia.

It may sound counter-intuitive, but decreasing the flow of blood into shoulder tissue significantly reduced the patients’ pain and inflammation.

"We were shocked at the profound and dramatic improvement patients experienced in pain and use of their shoulder," says Bagla. "We are early in the investigation of this treatment but are inspired by its effectiveness in reducing pain and range of motion in patients' shoulders."

The treatment was conducted on an outpatient basis and takes about one hour. Nine patients reported minor side effects such as skin discoloration.

The findings were recently presented in a research abstract during a virtual session of the Society of Interventional Radiology. The authors note that AES is still investigational and that conservative therapies for frozen shoulder should still be considered first.

Tiny Implant Could Revolutionize Stimulators

Pat Anson, PNN Editor

Engineers at Rice University have created a tiny implant – about the size of a grain of rice -- that can electrically stimulate the brain and central nervous system without using a battery or wired power supply.

The magnetically powered implant generates the same kind of high-frequency signals as much larger battery-powered stimulators used to treat chronic pain, epilepsy, Parkinson's disease and other medical conditions. It could be implanted almost anywhere in the body in a minimally invasive procedure.

Researchers demonstrated the viability of the implants by placing them beneath the skin of laboratory rodents that were fully awake and free to roam about their enclosures. The rodents preferred to be in portions of the enclosures where a magnetic field activated the stimulator, which provided a small voltage to the reward center of their brains.

"Doing that proof-of-principle demonstration is really important, because it's a huge technological leap to go from a benchtop demonstration to something that might be actually useful for treating people," said Jacob Robinson, PhD, a member of the Rice Neuroengineering Initiative and corresponding author of a study published in the journal Neuron.

"Our results suggest that using magnetoelectric materials for wireless power delivery is more than a novel idea. These materials are excellent candidates for clinical-grade, wireless bioelectronics."

The implant has a thin film of magnetoelectric material that converts magnetic energy into electricity. Lead author Amanda Singer created the film by joining together two layers of very different materials.

The first layer, a magnetostrictive foil of iron, boron, silicon and carbon, vibrates at a molecular level when it's placed in a magnetic field. The second layer, a piezoelectric crystal, converts mechanical stress directly into an electric voltage.

This method avoids the drawbacks of radio waves, ultrasound, light and other wireless methods to power stimulators, which can interfere with living tissue or produce harmful amounts of heat.

RICE UNIVERSITY

"The magnetic field generates stress in the magnetostrictive material," Singer explained. "It doesn't make the material get visibly bigger and smaller, but it generates acoustic waves and some of those are at a resonant frequency that creates a particular mode we use called an acoustic resonant mode."

Acoustic resonance in magnetostrictive materials is what causes large electrical transformers to audibly hum.

"A major piece of engineering that Amanda solved was creating the circuitry to modulate that activity at a lower frequency that the cells would respond to," Robinson said. "It's similar to the way AM radio works. You have these very high-frequency waves, but they're modulated at a low frequency that you can hear."

Tiny implants capable of modulating the brain and central nervous system could have wide-ranging implications. They could replace battery-powered implants used to treat epilepsy and reduce tremors in patients with Parkinson's disease. Neural stimulation could also be useful for treating depression, obsessive-compulsive disorders and chronic intractable pain.

Singer said creating a signal that could stimulate neurons without harming them was a challenge, as was miniaturization.

"When we first submitted this paper, we didn't have the miniature implanted version," she said. "When we got the reviews back after that first submission, the comments were like, 'OK, you say you can make it small. So, make it small.’

"So, we spent another a year or so making it small and showing that it really works. That was probably the biggest hurdle. Making small devices that worked was difficult, at first."

In all, the study took more than five years to complete, largely because Singer had to make virtually everything from scratch.