Cefaly for Acute and Preventive Treatment of Migraine. 2023
Migraine is a genetically inherited, neurobiological illness consisting of moderate to severe one-sided, throbbing headaches that come with sensitivity to light and noise and nausea and vomiting. Migraine is very disabling and occurs more frequently and severely in women where it relates to estrogen, and less often in men.
Because it is a chronic medical problem lasting usually from late teens and early twenties till past menopause or age 50, persons with migraine need to learn to treat their migraines and this usually means that they have to take medications, which may help, but also may cause unwanted side effects. Medication side effects may prevent effective migraine treatment. There is a need for an alternate treatment for Migraine that doesn’t involve taking pills.
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Migraine patient victim in bed with a headache.
This is an article by Britt Talley Daniel MD, member of the American Academy of Neurology, the American Headache Society, migraine textbook author, podcaster, YouTube video producer, and blogger.
Cefaly for Migraines. Cefaly is an electronic device that provides neurostimulation of the trigeminal nerve and is used for acute and preventive treatment of Migraine.
Cefaly attaches by an electrode to the forehead and sends pulses to the upper branch of the trigeminal nerve which regulates migraine pain.
Cefaly is available over the counter without a prescription and is a medical device which has very few side effects. It can help persons with migraine who don’t want to take or who respond poorly to usual migraine medications.
Cefaly is the alternate treatment solution that persons with Migraine who do not respond well to oral or injectable medications need.
Related questions
What is Cefaly ?
Cefaly is an External Trigeminal Nerve Stimulator or (e-TNS). It works through neurostimulation, providing modulation of the nervous system.
Cefaly can significantly reduce medication use and improve the quality of life for migraine patients. The device came out in 2008 and has been reviewed favorably for effectiveness and safety by multiple medical journals.
It is approved by the FDA, under prescription, for the prevention of migraine attacks or for acute therapy of a migraine with or without aura type attack.
What is neurostimulation? Neurostimulation is the electromagnetic harmonizing of nervous system activity using transcranial electrical stimulation.
Does neurostimulation work for reducing pain? Neurostimulation technology can provide reduction of severe pain through transcranially applied electrical currents.
Where did electrical stimulation for medical purposes come from? In 46 AD Scribonius Largus first used electrical stimulation from torpedo fish (electric ray) to relieve headaches.
Late in the 18th century, Luigi Galvani discovered that the muscles of dead frog legs twitched when stimulated electrically.
In 1870 it was found that electrical stimulation of the motor cortex of dogs caused limb movement.
In today’s world sensory devices, such as visual implants, cochlear implants, auditory midbrain implants, spinal cord stimulators, motor prosthetic devices, such as deep brain stimulators, and cardiac electro-stimulation devices are widely used.
How is Cefaly used? The device can stop a migraine in progress and prevent future episodes also. This electronic medical device can provide migraine treatment without the use of medication. It can help persons with migraine and overtreatment causing Medication Overuse Headache.
Cefaly® technology addresses the different phases of migraines and there are now three treatment options:
Cefaly® PREVENT, a prophylaxis treatment
Cefaly® ACUTE, a rescue treatment
and Cefaly® DUAL, a device that combines both prevent and acute technologies.
Dr. Pierre Rigaux, the chief executive officer of CEFALY Technology, and a member of the team that invented the device said. “We have developed a way for migraine patients to stop a migraine and prevent a migraine without medication and with next-to-no side effects.”
How is Cefaly Administered? The device is placed on the forehead via a magnetic connection to a self-adhesive electrode which then sends precise micro-impulses through the skin to the upper branches of the trigeminal nerve to either relieve headache pain during a migraine attack or to prevent a future migraine attack.
Cefaly Acute setting would be used during a migraine attack. The patient should use this setting for a 1-hour session during the migraine to stop the attack and relieve the headache pain.
Cefaly Prevent setting provides migraine prevention and it is designed to be used 20 minutes per day, by people experiencing migraine symptoms three or more times per month.
This setting changes the trigger threshold of the migraine to reduce the frequency of migraine days.
“I can read your thoughts.. No! I mean, it’s a device for my migraines.”
How is Neurostimulation performed? Neurostimulation was applied via the e-TNS Cefaly® device (CEFALY Technology, Seraing, Belgium) for a 1-hour session. The device is a constant current generator for a maximum skin impedance of 2.2 kΩ that delivers rectangular biphasic symmetrical pulses with a zero electrical mean.
The pulse frequency used in the current study for the verum device is 100 Hz and pulse width is 250 µs; the total maximum dose of current delivered by a 1-hour session is 1.284 C.
The intensity increases linearly to reach a maximum of 16 mA after 14 minutes and then remains constant for 46 minutes.
The electrical pulses are transmitted transcutaneously via a supraorbital bipolar self-adhesive electrode (30 × 94 mm) placed on the forehead, designed to cover and excite (trigger action potentials) the supratrochlearis and supraorbitalis nerves bilaterally.
Dr. Frankenstein, “He’s alive!! He’s alive!
Chill, it’s not that big of a pulse.
What are the results of using Cefaly? The new FDA-approval follows several clinical trials that demonstrated that one hour of e-TNS with the Cefaly® ACUTE can relieve or stop a migraine headache.
Results from the acute treatment of migraine with external trigeminal nerve stimulation double-blind randomized placebo control trial were presented at a meeting of the International Headache Society.
The findings showed that on average, the Cefaly® treatment reduced migraine pain by 65%. In addition, 32% of patients were pain free within an hour.
What is the clinical effectiveness of using Cefaly? Neurostimulation of the trigeminal nerve with Cefaly© produces a sedative effect. Regular repetition of this sedative effect helps reduce the number of attacks of migraine.
Two studies, involving 87 patients, looked at how well the procedure works, and showed the following benefits after 3 months of treatment with the device:
fewer days with migraine
fewer migraine attacks each month
fewer days each month with any headache
less severe headaches
fewer migraine drugs needed each month
most patients were very or moderately satisfied.
What are the side effects of Cefaly? The side effects were not serious and were seen in a small number of patients. Side effects were:
‘Minor and reversible events’ (no further details provided) in 4% of patients.
Local pain or intolerance to paresthesia and a pins and needles feeling caused by the device in 2% of patients.
Skin problems in less than 1% of patients, including temporary local skin allergy, forehead skin irritation and a feeling of bruising on the forehead.
Arousal changes (mostly sleepiness/fatigue, sometimes insomnia, 19 subjects, i.e. 0.82%), headache after the stimulation (12 subjects, i.e. 0.52%).
Rare red, irritated skin from Cefaly.
How does Cefaly compare with pharmacological treatment of migraine? Current available acute migraine treatments are mainly pharmacologic therapies using analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and ‘migraine-specific’ drugs such as ergots, triptans, 1 gepant, and 1 ditan.
These drugs have incomplete efficacy, as well as side effects and contraindications.
Overdose of drugs for treating migraine may also lead to medication overuse headache and chronification of migraine.
Unfortunately, there are no reported studies comparing pharmacological treatment with use of Cefaly.
These limitations highlight the need for non-pharmacological options for acute migraine treatment such as Cefaly provides.
Too many pills. Medication overuse headache
What do studies on the use of Cefaly for acute migraine treatment show? Chou, et al, wrote in Neuromodulation. 2017 Oct;20(7):678-683 on External Trigeminal Nerve Stimulation for the Acute Treatment of Migraine: Open-Label Trial on Safety and Efficacy.
The authors assessed the safety and efficacy of external trigeminal nerve stimulation (e-TNS) via a transcutaneous supraorbital stimulator as an acute treatment for migraine attacks.
Materials and methods:
This was a prospective, open-labeled clinical trial conducted at the Columbia University Headache Center (NY, USA). Thirty patients who were experiencing an acute migraine attack with or without aura were treated with a one-hour session of e-TNS (CEFALY Technology) at the clinic.
Pain intensity was scored using a visual analogue scale (VAS) before the treatment, after the one-hour treatment session, and at two hours after treatment initiation. Rescue migraine medication intake was recorded at 2 and 24 hours.
Results:
Thirty patients were included in the intention-to-treat analysis. Mean pain intensity was significantly reduced by 57.1% after the one-hour e-TNS treatment (-3.22 ± 2.40; p < 0.001) and by 52.8% at two hours (-2.98 ± 2.31; p < 0.001).
No patients took rescue medication within the two-hour observation phase. Within the 24-hour follow-up, 34.6% of patients used a rescue medication. No adverse events or subjective complaints were reported.
Conclusions:
The findings from this open-labeled study suggest that transcutaneous supraorbital neurostimulation may be a safe and effective acute treatment for migraine attacks, and merits further study with a double-blind, randomized, sham-controlled trial.
What do studies on using Cefaly for migraine prevention show? Paola Di Fiore, et al, wrote in Neurological Sciences volume 38, pages201–206(2017) on Transcutaneous supraorbital neurostimulation for the prevention of chronic migraine: a prospective, open-label preliminary trial.
The abstract from that study follows:
Since chronic migraine is difficult to treat and often associated with medication overuse, non-invasive neurostimulation approaches are worth investigating.
Transcutaneous supraorbital neurostimulation using the Cefaly® device is promising as a non-invasive preventive treatment for episodic migraine, but no data are available for chronic migraine.
Our aim was to perform a preliminary evaluation of the efficacy of the Cefaly® device for the prophylaxis of chronic migraine with or without medication overuse. Primary endpoints were 50% reduction in monthly migraine days and 50% reduction in monthly medication use over 4 months.
In an open-label study, twenty-three consecutive headache center patients with chronic migraine, diagnosed according to International Headache Society criteria, were recruited prospectively. After informed consent, patients were trained to use Cefaly® and instructed to use it for 20 min daily over 4 months.
All patients received active neurostimulation. Thirty-five percent of the patients enrolled in the study achieved the study endpoints. Over half the patients had a greater than 50% reduction in acute medication consumption.
Doing all right with Cefaly.
How does one contact Cefaly for more information? For more information, visit http://www.cefaly.us. Find Cefaly on Twitter: @Cefaly and on Facebook: http://www.facebook.com/CefalyEN.
About Migraine
Migraine is classified according to the International Classification of Headache Disorders 3 as episodic migraine, which is less than 15 migraine headache days a week, or chronic migraine which is 15 or more headache days a week, eight of which have migraine features.
However, migraine is a chronic neurologic genetically and family related medical problem. For women migraine is their most common medical problem affecting 25% of women. 6% of men have migraine.
The occurrence of migraine attacks may be migraine without aura as described above or migraine with aura which comes with the visual appearance of spots, holes, seeing half of things, or luminous zig-zag lines which usually appear before the headache starts.
Summary
Cefaly provides treatment for acute and preventive Migraine treatment. It works well for persons who have failed usual Migraine pharmaceutical treatment and who don’t want to take shots or pills. Using Cefaly can avoid medication overuse headache.
Check out my Big Book on Migraine Here.
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Britt Talley Daniel MD
