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Potential new neuromodulation treatment for migraines


 

Most people avoid smartphones when they have a migraine headache, but a noninvasive treatment for episodic migraines may change that.

A smartphone-enabled device, cleared by the Food and Drug Administration in early 2021, uses technology to trick the brain into releasing the neurotransmitters serotonin and noradrenaline that can help ease migraine pain.

Tina Montgomery, 58, has suffered from migraines since childhood and spent years looking for something to help manage them. Doctors consider her a “chronic” sufferer in that she has more than 14 migraines a month (fewer than 14 is considered “episodic”). Prescription antidepressants, anticonvulsants, and botulinum toxin shots as preventive treatments helped a little but not enough.

A few years ago, she found some relief using a new preventive injectable medication that targets a peptide known as CGRP, combined with an oral CGRP rescue medication, ubrogepant (Ubrelvy). However, by early 2021, Ms. Montgomery’s chronic migraines were back as she faced stress from the pandemic and her role as a caregiver for her aging parents.

“I was going through so much medication. I just didn’t feel good taking so much,” she said.

Looking for relief, she read about Nerivio, a wearable migraine treatment device that uses remote electrical neuromodulation (REN). She mentioned the device to her neurologist, and he agreed she might benefit from trying it out. Today, she uses the device whenever she feels a migraine may be imminent, she said.

“It really helps me stave off migraines I feel coming on and the milder ones where I would normally hesitate to use prescription medication because [insurance] limits the number of pills they give you in a month,” she said. “I follow through with the Nerivio treatment and usually find that my migraine doesn’t fully develop or is completely gone, and I don’t get a migraine at all.”

Taking it on the arm

The device works by stimulating nerves at the back of the arm right around the triceps. “Those nerve fibers relay information to the brain stem [so it can] work its magic and use the brain’s own natural mechanisms for reducing pain,” said Brian M. Grosberg, MD, director of the Hartford Healthcare Ayer Neuroscience Institute Headache Center, West Hartford, Conn.

These mechanisms are like a bait-and-switch for the brain, said Britany Klenofsky, MD, assistant professor of neurology, Icahn School of Medicine at Mount Sinai, New York. “You’re trying to stimulate pain somewhere else [on the body] to tell the brain to protect itself and release [the neurotransmitter] serotonin,” she said. “You do this by putting the device on your arm, an area that’s away from the head where the pain is actively occurring, turning the device on, and increasing the stimulation to a nearly painful stimulus.”

This pseudo pain prompts the brain to release serotonin, the feel-good hormone along with norepinephrine and noradrenaline. The device works best when it’s used as soon as a migraine starts, so patients should hook up Nerivio within the first 20-30 minutes of onset of pain, said Dr. Grosberg, who was an investigator on the double-blind treatment study that led to FDA clearance. If patients wait too long, the device may not work.

This is why as soon as Ms. Montgomery feels a migraine aura (there are six types of migraine auras, including visual changes and muscle weakness) that occurs right before a migraine strikes, she puts the device armband on her upper arm and launches its smartphone app. Then she turns on the device for a 45-minute treatment, which begins with what she characterizes as tingling and vibration sensations on her arm. She turns up the intensity of the sensations, which are mild electric currents, until they are well-felt but not painful.

Ms. Montgomery said she can use the device and multitask since there’s no need for her to lie down or sit in a darkened room. And since it is worn on the arm, she can wear it under a shirtsleeve while working or out in public without anyone noticing. She also uses the app’s migraine diary and guided meditation to help reduce the anxiety that often accompanies her migraines.

The device is approved for adolescents and adults and can be used for both episodic and chronic migraines. From an efficacy standpoint, the device provides relief about as well as a commonly used pharmaceutical class of drugs, triptans. About 37% of people with episodic migraine achieved complete freedom from pain 2 hours after their treatment. In addition, about two-thirds of people reported pain relief after 2 hours, which is better success than people find with many prescription and nonprescription drugs.

A separate study looked at acute treatment for chronic migraine sufferers and found nearly 60% of people using the device found relief and 21% said they were pain-free after 2 hours. Almost two-thirds of those who experienced pain relief were pain-free 24 hours after the treatment.

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