Non-Invasive Neuromodulation Devices

How new devices are impacting migraine treatment

Neuromodulation devices are advanced medical tools that can enhance or suppress the activity of the nervous system. Recent research has found this technology effective in reducing migraine attacks and cluster headaches. Some of these devices can terminate attacks that are already underway; others can be used to prevent attacks.

So far, three of these devices have been approved by the Food and Drug Administration. Stewart Tepper, M.D., Professor of Neurology at the Geisel School of Medicine at Dartmouth and Director of the Dartmouth Headache Center, explains how each device works, and what these advancements could mean for the future of migraine.

The Three Types of Neuromodulation Devices

The Transcutaneous Supraorbital Neurostimulator

This FDA-approved device, known more commonly as the Cefaly Device, uses electrodes for stimulation. Patients place the electrodes on their forehead, connect the device to the electrodes, and then turn it on. Once on, it stimulates the supraorbital nerves, which transmit that signal to the brain.

Cefaly is approved by the FDA for both preventative and acute treatment of migraine. Preventative treatment with the Cefaly Device lasts for 20 minutes daily. Acute treatment, with a different setting of the device, lasts one hour.

“If those with migraine do this every day over three months, gradually the number of migraine attacks can go down,” Tepper says. A prescription is required to purchase this device, which is generally not covered by insurance. The Cefaly Device which has settings for both acute and preventative treatment is called Dual, and costs, with electrodes and shipping, $540. It can be returned within 60 days for money back, but preventive effects generally take 3 months. Electrodes needs to be replaced about every 3 months for $25.

The Single Pulse Transcranial Magnetic Stimulator

The Single Pulse Transcranial Magnetic Stimulator device, also known as SpringTMS or sTMS, which simulates using a magnet rather than electrical pulses, is also FDA approved for both acute and preventative treatment of migraine.

“You put it on the back of your head, press a button, and the magnet is discharged,” Tepper says. “You don’t feel anything. It’s a minimal risk device.”

The curved, plastic device delivers a magnetic charge in about a second. It’s easy to use and can be transported easily. Patients will need a prescription to obtain the device, which can be rented in 3-month increments of about $200 per month, and there are some discounts available for first-time users. The preventive dose is 4 pulses of the magnet twice daily, with as needed extra pulses for acute treatment to a maximum of 17 pulses per day. Again, it takes about 3 months of daily use for prevention to be effective.

The Non-Invasive Vagus Nerve Stimulator

The third FDA-approved device, the Non-Invasive Vagus Nerve Stimulator, or nVNS, called gammaCore, uses electrodes to treat attacks of episodic cluster headache. The patient applies gel on the device, places it on the side of the neck, then turns the device on. It is programmed in cycles to stimulate for two minutes, and one treatment consists of three cycles.

As noted, the device is FDA approved for acute treatment of episodic cluster headache attacks and the acute treatment of pain associated with migraine headache in adult patients.

The cost of one month of use of gammaCore is currently $575.

Other Non-Invasive Devices

There are other, similar non-invasive devices in development that are not yet FDA approved. One the Nerivio Migra, which is an acute treatment used during a migraine attack to terminate symptoms with 25 minutes of electric stimulation. It’s a remote-controlled, pain-free stimulator that sticks on the patient’s arm, and is controlled by a smartphone app.

Another emerging device is the Caloric Vestibular Stimulator. It has an internal computer system and activates stimulation through prongs inserted in the patient’s ear, like headphones. It works by heating and cooling the vestibular nerve inside the ear. This leads to changes in the brain, gradually reducing migraine frequency over 3 months when stimulating 20 minutes twice daily.

A similar, minimally invasive device called a sphenopalatine ganglion (SPG) simulator, named Pulsante, is also attracting attention for its efficacy in cluster treatment. A small device is inserted into the skull above the teeth by a trained surgeon. When in place, one end sits over an area outside the brain in the skull called the SPG. An external remote control is placed by the patient against the cheek, where it wirelessly connects with the device and turns on the stimulator. This device can terminate chronic cluster attacks acutely, in some patients prevent cluster attacks, and in some, do both.

Why use a neuromodulation device?

Neuromodulation devices can help prevent, reduce and stop headache attacks, often without the need for medication. This can be valuable for people with migraine who face an elevated risk of medication overuse headache, but many people prefer non-drug treatment.

“If you had a device that could terminate a migraine attack without a drug, why wouldn’t you try that first, if it didn’t have side effects?” Tepper said. “If you had a device that you could turn on twice a day, or three times a day, and prevent your migraine or cluster headaches without a drug, why wouldn’t you want to do that before you took a daily medication, or before you came in every three months to get Botox? Many people would much prefer a non-invasive neuromodulation device to a medication, or 31 injections every three months.”

While these new these treatments are not yet commonly prescribed, Tepper said he hopes that changes.

“At this juncture, a lot of specialists who take care of headaches have no experience with these treatments at all, because they came out of the pain area. But that doesn’t mean the use of these devices is very hard—it’s not. And that doesn’t mean they are not effective—they are. And that doesn’t mean that we all won’t be using these shortly. I’m hoping that’s the way it goes,” he said.

 

To stay up to date on emerging migraine treatments and technologies, subscribe to the American Migraine Foundation newsletter and join our Move Against Migraine Facebook group for direct access to leading headache specialists, updates on new innovations and a community of supporters and advocates who understand.