Anti Migraine devices

Supraorbital Stimulation

In supraorbital stimulation, or external trigeminal nerve stimulation (e-TNS) — sometimes referred to as transcutaneous electrical nerve stimulation (TENS) — your doctor recommends a specific level of microimpulses that target the upper branch of the trigeminal, or supraorbital, nerves, which research suggests are involved in migraine attacks.

These pulses are delivered using a device that you place on your head when you feel a migraine attack coming on, or during an attack to relieve pain. The device is available with a prescription or over-the-counter (no prescription required) in many pharmacies.

Once your doctor has suggested an appropriate level of stimulation for your migraine symptoms, you administer the treatment yourself at home.

Cefaly

The Cefaly Dual external e-TNS device is designed to be worn on the forehead. It uses magnets to attach to a reusable electrode that sticks to the skin with adhesive. The device can be used once daily for 20 minutes to prevent attacks and for up to 60 minutes during a migraine attack to relieve symptoms. The user chooses a preventive or acute program when applying the device and selects the intensity of the treatment. The device turns off automatically when the program is complete.

The Cefaly Dual, when sold as a package with 18 electrodes, each good for multiple uses, retails for about $500. The user will also need a charger and charging cable. Payment plans are available for those who qualify.

Relivion

Another e-TNS device, Relivion is a noninvasive headset that delivers pulses of electrical current to stimulate the occipital and trigeminal nerves.

In the clinical trial on which the FDA based its approval, the results of which have not yet been published in a professional journal, 46 percent of users reported pain freedom at two hours, and 75 percent reported freedom from their most bothersome symptom — nausea, light sensitivity, or sound sensitivity — at two hours.

Vagus Nerve Stimulation

GammaCore Sapphire

GammaCore Sapphire is an FDA-cleared (in 2015) handheld device that allows users to self-administer small doses of noninvasive VNS therapy to treat cluster headaches and migraine. The rechargeable and reloadable device is designed for multiyear use.

The device can be used for both acute and preventive migraine and cluster headache treatment. Users apply conductive gel to the two stimulation surfaces, then hold the device against the side of their neck, just below the jawline (either side of the neck will work), so that it can deliver small electrical pulses to the vagus nerve for two minutes at a time. The user controls the intensity of the pulses.

GammaCore Sapphire requires a doctor’s prescription. Before use, the device must be activated with an authorization code, delivered via a radio-frequency identification card.

Without insurance, the GammaCore starter kit, preloaded with three months of therapy, costs $450. However, some healthcare insurance plans cover the device and will reimburse at least some of the charges.

Remote Electrical Neuromodulation

Remote electrical neuromodulation (REN) may be particularly useful for people with migraine who are worried that using devices that apply electrical stimulation to the head area may worsen the pain associated with attacks. Uniquely, this approach is designed to stimulate the peripheral nerves in the upper arm. It is thought to reduce migraine pain by modulating a deep part of the nervous system involved in pain control. Specifically, REN activates pain control centers in the brainstem (the connection between the brain and the spinal cord), which blocks the pain signaling that occurs in migraine.

Currently, REN is designed to be used at the first sign of a migraine attack.

A study published in the September 2020 issue of the journal Pain Medicine found that up to 74 percent of people who used REN experienced pain relief within two hours, while up 36 percent of them were pain-free by that time. Less than 1 percent of the people in the study who used the approach had any related side effects.

Nerivio

Nerivio is available only with a doctor’s prescription at participating pharmacies and telemedicine providers. The first Nerivio device costs $10 with the Nerivio Express Savings Program, which requires that you have a pharmacy or medical insurance plan and that you give the pharmacy permission to run a benefits verification and receive any required prior authorizations. The cost of refill devices depends on the customer’s insurance coverage plan.

Effective, Well-Tolerated by Most, but Expensive

Although the side effects of nerve stimulation differ depending on the approach used, most are mild, such as redness or irritation and muscle twitching in the area where the device is applied. A handful of people undergoing nerve stimulation have reported feeling light-headed or having a tingling sensation after treatment.

Keep in mind, also, that there are situations in which nerve stimulation can’t be used. People with epilepsy or implanted electrical devices like cardiac pacemakers probably shouldn’t use the technology, Robbins notes. It may be a good choice for people who are avoiding taking medications because they are pregnant or plan to become pregnant, are older, or are taking many other medications, he says.

The self-administered devices can be expensive and most aren’t covered by health insurance.

Despite these considerations, nerve stimulation has an important advantage over most migraine medications. “Some drugs have been linked with what’s called medication-overuse headaches — headaches associated with repeated use of the medications themselves,” Robbins notes. “There doesn’t seem to be the same issue with nerve stimulation. To be honest, it’s a treatment I’d recommend to more patients.”

Single-Pulse Transcranial Magnetic Stimulation

A potential preventive and acute treatment for migraine , sTMS can be administered at home by placing the sTMS device against the back of your head and activating it. The device delivers a short magnetic pulse (the length is preset by your doctor) that targets the layers of the scalp, the skull, the meninges (membranes that enclose the brain and spinal cord), the cerebrospinal fluid, and the superficial layers of the cortex, where it modulates the electrical environment of neurons involved in migraine attacks.

In a study published in May 2018 in the journal Cephalalgia, sTMS reduced the number of days that people with migraine experienced symptoms. Users also had a decreased need for rescue medication.

SAVI Dual

The eNeura SAVI Dual is an FDA-approved sTMS device that is battery powered, handheld, and can be used for both the prevention and treatment of migraine attacks in adults and children age 12 and older.

The user places and holds the SAVI Dual firmly against the back of the head to cradle the base of the skull. With the push of a button, the device’s specially shaped electrical coils deliver a magnetic pulse designed to treat and prevent migraine attacks by interrupting abnormal electrical activity in the brain associated with them. The device automatically transmits a person’s treatment history to a cloud-based diary, which can be used to improve migraine management.

You need a doctor’s prescription to use the SAVI Dual. A $350 monthly prescription fee includes unlimited acute treatments and daily preventive treatments.

Implantable Occipital Nerve Stimulation

Notably, ONS is different from other nerve stimulation systems in that it involves surgery, but the procedure is reversible.

One implantable device currently in development, from Salvia Bioelectronics, uses mild electrical impulses to influence nerve activity, or the pattern of electrical impulses transmitted through nerve fibers that control how your body functions. The Dutch company is working on implantable thin bioelectronic foils that conform to the shape of the head to deliver neurostimulation.

Specifically, the company’s implantable neurostimulation system (similar to a pacemaker) will be designed to use bioelectronic foil technology to disrupt the brain processes that cause migraine attacks in people for whom drug therapy has failed. In 2020, the FDA granted Salvia a breakthrough device designation for its implantable technology. The designation enables the company to have more frequent interaction with FDA regulatory experts as it prepares the device for approval.