A New Non-Drug Option
for Migraine Treatment
In March, 2014, for the first time, the Food and Drug
Administration (FDA) granted approval to a transcutaneous
neurostimulation device for the preventative treatment of
episodic migraine headaches. However, the technology
has been used for decades, for pain control as well
as rehabilitation. This device provides “supraorbital”
transcutaneous stimulation. Supraorbital refers to the area
right above the eye sockets, at the eyebrows. Electrical
impulses are used to send a signal through the skin to the
trigeminal nerve. At this point, it works to desensitize the
trigeminal center in the brain which has been identified as
playing a major role in migraine headaches. The superior
branch of the trigeminal nerve ends at the exit of the eye
socket, underneath the skin of the forehead. The device
stimulates this nerve by sending precise micro-impulses
during 20-minute sessions. This helps to desensitize the
nerve and reduce the number of migraine attacks.
The published study on this method of treatment was
undertaken in Belgium, at five tertiary headache centers.
The study involved 67 subjects who were required to
have at least two migraine attacks per month and were
randomized to 1 of 2 groups – actual stimulator or sham
stimulator. However, the patients who participated in
the study experienced just slightly less than seven attack
days per month. The majority of these patients may be
considered as having low frequency migraine which
is defined as less than 9 headache days per month. The
treatment period was 3 months. The patients were to apply
the device for 20 minutes daily. At the end of the 3 months,
monthly migraine days were measured and compared to
the baseline frequency of their migraine attacks. There was
no significant difference between the sham group and the
treatment group. However, a significant difference was
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HeadW ise ®
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Volume 4, Issue 2 • 2014
noted in monthly attack frequency and the use of acute/
abortive medications in those subjects using the actual
device. Between the groups, there was no significant
difference in headache severity or associated symptoms,
including light and sound sensitivity. No side effects were
reported for either group. It should be noted by nature
of the study, it did not have a true placebo arm which is
an important part of research. Despite the study size, the
device received approval from the FDA for the prevention
of migraine.
In a much larger study, in Belgium, the device was shown
to be a safe treatment with few side effects. However, nearly
one-half of the study subjects stopped treatment after 60
days for several reasons. In this study, the most common
side effects after stimulation were local pain/intolerance to
numbness and tingling, arousal changes (mostly fatigue/
sleepiness), occasional insomnia, and headache.
The stimulator is battery-operated and resembles a
headband or a tiara, and is manufactured by CEFALY
Technology in Belgium. Once it received approval, the
device began to ship to the U.S. in April. “The FDA
approval of the Cefaly® medical device is significant,”
said Doctor Pierre Rigaux, the chief executive officer of
CEFALY Technology and one of its inventors. “Migraine
patients now have a neurostimulation device of their very
own.”
The drug-free, prescription-only treatment, is used for
20 minutes per day. According to reports, the device has
been providing relief for many patients who are unable or
unwilling to take medication. It has also been utilized by
patients who are currently on pharmacologic therapy, but
are seeking to improve their results.
Denise Chou, MD, Assistant Professor of Neurology and
Director of the Columbia University Headache and Facial
Pain Center in New York City, noted about her patients: “I
may often use Cefaly concurrently with medication with
the goal either of expediting their progress or weaning them
off of their medication. Although Dr. Chou has treated
some patients with high doses of preventive medications,
she reports some patients using the device on a routine
basis managed to stop their medications. However, she
stresses that each patient is different as is each migraine
attack.
“It’s definitely not a blanket solution,” she said. “I’ll
recommend the Cefaly device to patients if they have side
effects to medications or they’re concerned with potential
side effects to medications, or if they’ve tried some
medications and have some partial improvement. I’ll often
use this as opposed to adding another medication.”
Across the U.S., headache physicians rely on the
standard therapies: prophylactic medications to prevent
the occurrence of migraine attacks; abortive medications
to resolve a migraine attack once it has started; and,
rescue medications to provide relief of the acute pain and
the associated symptoms. Some headache specialists will
recommend alternative therapies, such as acupuncture,
biofeedback, and herbal therapies. A device providing
trigeminal neurostimulation is one more tool to combat
migraine attacks.
Some headache patients may be familiar with
transcutaneous electrical nerve stimulators (TENS devices)
that have been available in the U.S. since the mid-1970s.
Until now, the non-invasive nerve stimulation treatment
was most familiar to patients with chronic neck and lower
back pain. The FDA has categorized the Cefaly device as a
TENS unit but more specifically, it is an external trigeminal
nerve stimulation (eTNS).
Cefaly is indicated for patients 18 years of age and older
and should only be used once per day for 20 minutes.
It is only available by prescription and must be ordered
online. The NHF reported on this device a year ago, when
it was still being evaluated. At the time, Arthur Elkind,
MD, the president of the NHF’s board of directors, urged
migraineurs to be cautious about buying this new tool and
suggested they wait for regulatory approval in the United
States. Now that approval has been granted, Doctor
Elkind said he b