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Treating Migraines: More

Ways to Fight the Pain

hought there was no hope

for treating your migraine
headaches? Dont give up.

In the past year, the Food and Drug

Administration has given adults
new options for treating migraines
by allowing the marketing of two
prescription devices for such headaches. People who dont tolerate drug
treatments well might find relief by
using the Cerena Transcranial Magnetic Stimulator or the Cefaly transcutaneous electrical nerve stimulation
device. Both devices have been shown
in clinical studies to be effective and
pose minimal risks and side effects
when used according to their labeling.
Theres a great need for these noninvasive devices because many antimigraine drugs have side effects that
some patients cant tolerate, says
Michael Hoffmann, a biomedical
engineer with FDA.
A drug may have the potential
for systemic side effects because its
ingested and metabolized. It may also
have a variety of side effects that vary
from person to person, Hoffmann
explains. Patients have been looking
for alternative migraine treatments.
Because these devices arent ingested
or metabolized like drug therapies,
they dont necessarily have the same
types of side effects.

Two New Devices

Migraine headaches are characterized by intense pulsing or throbbing
pain in one area of the head accompanied by nausea and/or vomiting

and sensitivity to light and sound.

A migraine can last four to 72 hours
when untreated. According to the
National Institutes of Health (NIH)
(http://www.nlm.nih.gov/medlineplus/
migraine.html), 12 percent of Americans (about 37 million people) have
migraines. These debilitating headaches affect children and adults, and
women are three times more likely to
have migraines than men (about 18

1 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion

percent of women have migraines).

About one-third of people with
migraines experience an auravisual
disturbances such as dots, flashing
lights or a blind spotthat signals the
beginning of the headache. Cerena is
the first medical device granted marketing by FDA to relieve pain caused
by migraine headaches that are preceded by an aura.
Patients use Cerena when they feel
SEP T EMBER 2014

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Bastings advises patients to tell their

health care providers about their headaches
and to see a doctor who specializes in
migraines if they dont get adequate relief.
a headache coming on or when the
pain begins. Using both hands to
hold the device against the back of
the head, the patient presses a button
to release a very short (less than one
second) magnetic pulse to stimulate
the brains occipital cortex (the back
part of the brain that processes visual
information). Transcranial Magnetic
Stimulator (TMS) technology, used
in the Cerena device, has been studied for quite some time but has only
recently been authorized for specific
clinical uses.
Cefaly is the first transcutaneous
(passing through the skin) electrical nerve stimulation (TENS) device
granted marketing by FDA for use
before the onset of a migraine, as a
preventive treatment for migraine
headaches. Patients can use Cefaly
daily, and the treatment has been
shown to reduce the number of
days during which they experience
migraines. TENS technology has been
around a long time as a treatment for
general pain, but this is the first time
its been authorized as a preventive
measure for migraines.
The por table, batter y-powered
Cefaly device resembles a plastic
headband worn across the forehead.
The user applies an electrode (a
patch) to the forehead, connects the
plastic headband to the electrode,
and the device then emits an electrical current to stimulate one of the
large nerves in the head (the trigeminal nerve), which has been associated with migraines. Its a set-time
therapyrunning for 20 minutes

and stopping automatically, Hoffmann says.

Both devices side effects include
skin irritations, discomfort, sleepiness,
dizziness and pain at site of application. These issues werent reported
often and were resolved quickly, Hoffmann says. For example, in a telephone poll of more than 2,000 European users of Cefaly, 95 percent did
not report any complaint with using
the device. But the safety and effectiveness of these devices have not been
established in certain populations,
including children, pregnant women
and people with pacemakers.

Limitations of Drugs
Although there are effective drug
treatments for migraines, they can
have side effects. Medical devices
aim to provide an alternative treatment with fewer and more tolerable
side effects.
There are many drugs to reduce
migraine pain and symptoms, says
Eric Bastings, M.D., a neurologist at
FDA. Although these drugs are quite
effective, they are not for everyone.
Some can make you tired, drowsy or
dizzy. Some can affect your thinking.
And some migraine drugs can cause
birth defects; so pregnant women
cant use them, he adds. Its important to note that medical devices have
some limitations as well, and that
the safety and efficacy of Cefaly and
Cerena have not been established in
pregnant women.
Many people who have frequent
or severe migraines may use preven-

2 / FDA Consumer Health Infor mat ion / U. S. Food and Drug Administrat ion

tive medications, including betablockers such as propranolol. Betablockers, which slow the heart rate,
are used mostly to treat heart conditions. These medications arent for
migraine patients who have asthma,
some lung problems or slow heart
rate, Bastings warns.
Certain antiepileptic drugs, such as
topiramate and divalproex sodium,
are also prescribed for migraines.
These seizure medicines, when they
are taken regularly, may help to reduce
the number of migraine headaches,
but rarely eliminate them completely.
Migraines are often underdiagnosed and undertreated. Bastings
advises patients to tell their health
care providers about their headaches and to see a doctor who specializes in migraines if they dont
get adequate relief. Doctors should
be aware of the drugs approved for
migraines and of alternative treatment options, he adds.
These devices present another
choice that patients can discuss with
their doctors, Hoffmann says. Now
patients have more options and hopefully can find the one that works best
for them.

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