Updated Device Helps Prevent Migraines

By Pat Anson, Editor

A new pocket-sized wearable device is available to help treat and prevent migraine headaches.

Cefaly Technology has released the Cefaly II, an updated version of the Cefaly I, which is worn over the forehead like a headband and uses small electrical impulses to stimulate the trigeminal nerve, which has been associated with migraine headaches.

The Cefaly II is much smaller and fits in the palm of a hand. Like its predecessor, the device is worn on the forehead, but is held more securely in place by a magnet. Because of its smaller size, the manufacturer believes the Cefaly II will be more accessible and easier to use.

“This compact device is so easy to tuck in a pocket or purse and I am hopeful it will further increase compliance and bring an even larger reduction in migraine attacks to patients,” said Dr. Pierre Rigaux, Chief Executive Officer of Belgium-based Cefaly Technology.

“Now that the device is so small, it’s a big deal because patients can have their Cefaly II with them wherever they go, which means they’ll be able to use it more readily, at their most convenient time.”

cefaly technology image

cefaly technology image

The Cefaly II uses a magnet to attach itself to a self-adhesive electrode worn directly on the forehead. The rechargeable, battery powered device sends tiny electrical impulses through the skin to desensitize the upper branches of the trigeminal nerve and reduce the frequency of migraine attacks. Patients have full control of their daily 20-minute session and can ramp up the intensity to their own comfort level.

In a small study of 20 migraine sufferers, published in The Journal of Headache and Pain, the Cefaly I provided "statistically significant" pain relief and an 81 percent reduction in the number of migraine attacks. Patients in the study also said they used significantly less migraine medication.

The electrode and output of the Cefaly II is identical to the Cefaly I, according to the company.

Here’s a company produced video of how the Cefaly II works:

The Cefaly II is only available by prescription and costs $349, with a 60-day money back guarantee. The device can be ordered online by clicking here. The Cefaly I will no longer be offered, but the electrodes for it will be available for another 5 years. Cefaly Technology has sold about 20,000 of the devices in United States and 80,000 outside the U.S.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

New Wearable Devices for Chronic Pain

By Pat Anson, Editor

With opioid pain medications becoming harder to get and many patients looking for safer alternatives with fewer side effects, a growing number of companies are offering wearable “electrotherapy” devices for pain relief.

There’s the Cefaly headband for migraines, ActiPatch for sore muscles, AcuKnee for osteoarthritis, and the Quell nerve stimulator, which is designed to treat a range of chronic pain conditions. All are part of a fast growing $2.8 billion market for wearable medical devices.

“There’s a big problem brewing on the horizon. And that is the pain medications are being removed from the market, slowly but surely,” says Phillip Muccio, President and founder of Axiobionics, which has been making customized electrotherapy devices for 20 years.

“Electrical stimulation has a way of reaching into the body and interacting and coordinating what happens to the body. That’s why it a fascinating area of medicine because not a lot of things will do that, especially non-invasively and non-pharmacologically.”

Most of the new devices use a form of electrical stimulation to block or mask pain signals – a technique developed decades ago known as Transcutaneous Electric Nerve Stimulation (TENS).

Unlike the old TENS units, which are typically used for about 30 minutes, wearable devices are designed to be worn for several hours at a time or even while sleeping.

image courtesy of axiobionics

image courtesy of axiobionics

“TENS is like a short acting opioid. It’s basically only effective when it’s on,” said Shai Gozani, MD, President and CEO of Neurometrix. “If you’re going to deal with chronic pain, you have to have a wearable, chronically usable device, because pain can be two hours a day or it could be 24 hours a day. TENS devices historically haven’t been designed at all for wear-ability or continuous use.”

Neurometrix recently introduced Quell, an electrotherapy device that Gozani compares to a spinal cord stimulator. But instead of being surgically implanted near the spine like a stimulator, Quell is worn externally on the upper calf below the knee.

image courtesy of neurometrix

image courtesy of neurometrix

“We really look at spinal cord stimulation as the model. We’re trying to make that available but in a non-invasive, wearable way -- versus TENS devices which are really intended for local muscle stimulation. We don’t stimulate the muscles, we stimulate the nerve alone,” Gozani told Pain News Network.

“The upper calf has a lot of nerves. It’s comfortable. It’s discrete. So it meets the requirement to have a large segment of nerves to stimulate, but it’s also highly usable from a wear-ability perspective.”

A small study recently conducted by Neurometrix found that over 80% of Quell users had a significant reduction in pain and two-thirds were able to reduce the amount of pain medication they were taking.  Participants in the study had several different types of of chronic pain, including fibromyalgia, sciatica, neuropathy and arthritis.

When it comes to clinical studies, medical device makers have a clear advantage over pharmaceutical companies, which often have to spend years and tens of millions of dollars proving the safety and effectiveness of their drugs before they’re approved by the Food and Drug Administration. Device makers are held to a lower regulatory standard.

“Devices are approved by FDA basically for safety and not necessarily for efficacy. It’s a lot easier to demonstrate that with a device than if you have to demonstrate a new drug. You basically run one study or two and show that nobody got electrocuted by a TENS unit and you’re good to go,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Device makers can even get fast track approval from the FDA without any clinical studies -- if they say a new device is substantially equivalent to an older device already on the market.  Quell, for example, was given clearance by the FDA because of its similarity to Sensus, another Neurometrix device that's worn below the knee for pain relief.

A significant disadvantage for device makers is that most are not covered by public or private health insurers – meaning patients have to pay for them out of pocket. Three years ago, Medicare stopped covering TENS for low back pain, saying the technology was “not reasonable and necessary.”

The lack of reimbursement also makes many doctors unwilling to prescribe wearable devices and unfamiliar with the technology behind them, which stifles innovation.  For that reason, Neurometrix took an unconventional path and made Quell available without a prescription – bypassing insurers and doctors so it could market directly to consumers for $249 a unit.

“We thought it was imperative to get it over the counter. We wanted to make sure it was accessible to patients," said Gozani. "Wear-ability changes everything. Wear-ability is the game changer in terms of optimizing pain relief. I think it's huge."

Migraine Device Reduces Headache Pain

By Pat Anson, Editor

A device that looks like a space age tiara not only helps prevent migraine attacks, but also relieves headache pain once a migraine starts, according to the results of a small clinical trial.

In a study of 20 migraine sufferers, published in The Journal of Headache and Pain, the Cefaly device provided "statistically significant" pain relief, as well as an 81 percent reduction in the number of migraine attacks. Patients in the study also said they used less migraine medication.

Cefaly was approved last year by the U.S. Food and Drug Administration as the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of migraine pain.  Previous studies of the device only focused on migraine prevention.

"This is great confirmation on what we thought about the high efficacy of Cefaly," said Dr. Pierre Rigaux, chief executive officer of Cefaly Technology, a company based in Belgium. "We knew Cefaly to be very safe and with minimal side effects, but now we learn that it's not just the frequency of migraine days that's reduced for every four out of five patients, but the intensity of pain during a migraine attack is reduced as well."

IMAGE COURTESY OF CEFALY TECHNOLOGY

IMAGE COURTESY OF CEFALY TECHNOLOGY

The battery-powered device, which is worn over the forehead like a headband, uses tiny electrical impulses to stimulate the trigeminal nerve, which has been associated with migraine headaches. Cefaly requires a prescription and costs about $349. The device is only available through the company’s website and is not covered by insurance. It’s been available in Europe and Canada for several years.

It was on a trip to Canada that Maria Coder learned about Cefaly and – at the urging of her boyfriend Jay– reluctantly agreed to buy one.

“At the time my boyfriend and I got into a big fight because he wanted me to use it right away and I didn’t really like the idea. I’d never heard of it and I was nervous about using it,” said Coder, who has suffered from migraine for nearly two decades.  

The device sat in its box for about a week before she finally tried it.

“I was alone in the apartment and put on the headband and loved it. I fell in love with it. I started to feel better, but I thought beginner’s luck,” Coder told Pain News Network. “I tried it a few more times and then it took on a life of its own. Now I feel like a wimp when I get a migraine because I don’t get them hardly ever compared to before. It’s down to maybe 3 to 5 a month, whereas for almost ten years it was chronic, almost daily.”

Coder, who works in public relations, wrote a letter to Cefaly Technology that eventually turned into a job as a publicist for the company. She also recently married her boyfriend – wearing the Cefaly device for her daily 20-minute session during a break after the ceremony and before her reception.

“I really love and I really believe in it. I didn’t believe in it at first, when I got it. And then the more that I used it, the more I couldn’t deny the results,” she said.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

maria coder

maria coder

In 2013, the FDA approved the marketing of another device -- the first transcranial magnetic stimulation (TMS) device approved for the relief of migraine pain. The Cerena TMS is placed at the back of the head to release a pulse of magnetic energy to the brain’s occipital cortex, which may stop or lessen pain caused by migraine headaches.