DENVER — A doctor in Denver is part of a study to get a new type of migraine treatment device approved by the U.S. Food and Drug Administration (FDA).
A neuromodulator that is made specifically to treat migraines may be a boon to those who suffer from them.
Migraines can be debilitating and are notoriously hard to treat. Dr. Giancarlo Barolat has seen it first-hand over the past 25 years.
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“It’s basically like the nervous system gets into a hyper mode where everything that happens around you is funneled into a headache," said Dr. Barolat. “I know a patient has migraines because the lights are off and the patient is wearing sunglasses in the dark because they can be so sensitive to light that the light will make the headaches 100 times worse.”
Dr. Barolat is one of the country's leaders in using neuromodulators to treat migraines. The device consists of a pacemaker to generate an electrical charge and a wire-shaped electrode to deliver the charge.
The electrodes were originally designed to go along the spine, not in the head, but Dr. Barolat found them to be an effective treatment for patients who have tried everything else.
“These are people that have severe headaches, that have tried many or all of the medications available, and they have failed,” said Dr. Barolat. “Either because they didn't help or because the side effects were worse than the treatment.”
For the procedure, a pacemaker is planted into the patient’s body, usually in the chest or lower back. Then, doctors run the electrodes under the skin and through the body, up to the front, side, or back of the head to directly treat the migraine symptoms.
“I received a note from a young woman that I implanted three years ago, and she was 18 years old,” said Dr. Barolat. “She couldn't do anything. This is an incredibly smart woman. She couldn't work, she couldn't study. She had headaches all the time... And we put this device in with four electrodes… and she went back to school, she graduated. Now, she just wrote to me that now, she spent a year in the UK studying. And she said, "I could have never done any of this if you had not done your procedure."”
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A company called Shiratronics is developing a type of neuromodulator that’s designed specifically to treat migraines. The pacemaker is smaller and fits inside the head near the ear, removing the need to have long cords run throughout a person’s body. People can be free to move as much as they want, with a reduced risk of breaking the leads on the electrodes.
The company is trying to get its product approved by the FDA. It is working with 15 centers around the country, including Harvard, The Mayo Clinic, and Dr. Barolat himself. If approved, more insurance companies would be willing to pay for the treatment. As it stands, many of them don’t currently pay for it.
“Right now, some insurance companies pay for it, [but] many don't pay for it. So that's an issue for a lot of patients,” said Barolat. “Hopefully, with this study, we'll be able to offer this to everybody.”
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