Cefaly the Transcutaneous Electrical Stimulator of Supraorbital Nerve
Cefaly Cranial TENS for Treatment and Prevention of Migraine and Headaches
Cefaly Anti-Migraine TENS fights Migraines, Headaches and Stress
Cefaly Migraine TENS delivers advanced external neurostimulation treatment for drug free relief of pain associated with Migraines, Headaches and Stress. Cefaly is a cranial TENS medical device utilising established neurostimulation therapy principles in a novel design applied to the forehead to prevent and treat chronic and recurrent headaches. Cefaly relieves pain and suffering caused by migraines, tension headaches, cluster headaches and stress related headaches. Cefaly can also help people experiencing painful discomfort of trigeminal neuralgia and frontal sinusitis. Since its launch in 2008, there are now over fifty thousands of Cefaly units in use, successfully helping the users to combat migraines. headaches and stress.
Cefaly is a Medical Device Class 2a (CE0499) under MDD 93/42/EEC (European Medical Devices Standards). In the USA, Cefaly gained FDA clearance. More recently, in June 2016 in the UK, the National Institute of Clinical Excellence (NICE) issued its recommendations for clinicians wishing to include Cefaly amongst their anti-migraine interventions.
Cefaly Transcutaneous Electrical Stimulator of Supraorbital Nerve and the NICE Guidelines for Clinicians
In June 2016, the National Institute for Clinical Excellence (NICE) issued evidence based recommendations for Transcutaneous Electrical Stimulation of the Supraorbital Nerve with small electrical currents for the treatment and prevention of migraine in adult sufferers. Such treatment of migraine related pain or to prevent further attacks constitutes of applying a headband device (CEFALY) designed to stimulate nerves located on the forehead under the skin.
NICE stated that whilst the current evidence on transcutaneous electrical stimulation of the supraorbital nerve for treatment and prevention of migraine is limited, it does not raise any major safety concerns.
NICE acknowledged the large amount of supportive comments received from Cefaly users. NICE also noted that the transcutaneous electrical stimulation of the supraorbital nerve for the treatment of acute attacks of migraines and headaches and for the prevention of migraine and headaches with Transcutaneous Electrical Stimulator of the Supraorbital Nerve Cefaly may be especially welcomed by people not wishing to take medication or wishing to reduce it or experiencing medication related side effects.
Cefaly, the Transcutaneous Electrical Stimulator of the Supraorbital Nerve can be used for the treatment of acute attacks of migraine as well as for prevention, if used on regular basis.
Clinicians wishing to use Cefaly for treating and preventing migraine should observe the NICE recommendations on Transcutaneous Electrical Stimulation of the Supraorbital Nerve in respect of clinical governance, consent and audit of clinical outcomes.
Cefaly is a medical device (CE 0499) that can be purchased and safely used by individual migraine sufferers. Enclosed with each Cefaly is a user manual with manufacturer’s recommendations on the correct use of Cefaly for best therapeutic outcomes.
*Cefaly and skin electrodes can be purchased VAT free for personal use by people suffering relevant chronic problems.
Please note: We do not ship Cefaly to the USA!
Cefaly Anti-Migraine Transcutaneous Supraorbital Neurostimulation Device clinical research
Research on the effectiveness and safety of Cefaly continues with wealth of positive data supporting the efficacy of Cefaly in migraine prevention growing.The following clinical survey study paper was recently published in the Journal of Headache and Pain:
Safety and patients’ satisfaction of Transcutaneous Supraorbital Neurostimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population.
Delphine Magis*, Simona Sava, Tullia Sasso d’Elia, Roberta Baschi and Jean Schoenen
Background: Transcutaneous supraorbital nerve stimulation (tSNS) with the Cefaly® device was recently found superior to sham stimulation for episodic migraine prevention in a randomized trial. Its safety and efficiency in larger cohorts of headache sufferers in the general population remain to be determined. The objective of this study was to assess the satisfaction with the Cefaly® device in 2,313 headache sufferers who rented the device for a 40-day trial period via Internet.
Methods: Only subjects using specific anti-migraine drugs, and thus most likely suffering from migraine, were included in the survey. Adverse events (AEs) and willingness to continue tSNS were monitored via phone interviews after the trial period. A built-in software allowed monitoring the total duration of use and hence compliance in subjects who returned the device to the manufacturer after the trial period.
Results: After a testing period of 58.2 days on average, 46.6% of the 2,313 renters were not satisfied and returned the device, but the compliance check showed that they used it only for 48.6% of the recommended time. The remaining 54.4% of subjects were satisfied with the tSNS treatment and willing to purchase the device. Ninety-nine subjects out of the 2,313 (4.3%) reported one or more AEs, but none of them was serious. The most frequent AEs were local pain/intolerance to paresthesia (47 subjects, i.e. 2.03%), arousal changes (mostly sleepiness/ fatigue, sometimes insomnia, 19 subjects, i.e. 0.82%), headache after the stimulation (12 subjects, i.e. 0.52%). A transient local skin allergy was seen in 2 subjects, i.e. 0.09%.
Conclusions: This survey of 2,313 headache sufferers in the general population confirms that tSNS with is a safe and well-tolerated treatment for migraine headaches that provides satisfaction to a majority of patients who tested it for 40 days. Only 4.3% of subjects reported AEs, all of them were minor and fully reversible.
Magis et al.: Safety and patients’ satisfaction of Transcutaneous Supraorbital Neurostimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population. The Journal of Headache and Pain 2013 14:95.
Cefaly and Headaches
Only the people suffering from frequent migraines and frequent headaches appreciate the full extend of the misery caused by their painful problem. Headaches and migraines can be chronic and occur frequently, sometimes even daily. They disrupt lives as normal daily activities may have to be put on hold, when a migraine strikes. Analgesics – pain killers - can be effective, but their effectiveness often reduces with long term use, requiring ever increasing doses to suppress the pain. Over consumption of drugs can further exacerbate the condition, leading to more frequent and more severe attacks.
If you are a migraine sufferer or if you experience frequent headaches, Cefaly can change your life! Cefaly’s gentle stimulation soothes stress, calms anxiety, inhibits pain and stops the headache. The treatment has powerful anti-stress effects, inducing wonderful feeling of wellbeing and relaxation.
Cefaly is a patented medical device supported by numerous clinical studies and safety tests as well as a growing number of satisfied user testimonials. Cefaly was clinically studied over 5 years in pain clinics at university hospitals and in specialist laboratories. In total, more than 5 thousand treatments were carried out to validate Cefaly’s clinical effectiveness. Cefaly utilises sophisticated technology to apply tried and tested TENS therapy in a novel style device that is lightweight, simple to use and proven effective.
Cefaly Anti-Migraine TENS - User Statistics
- 95% of users find Cefaly very simple to use
- 87% of users describe a definite improvement
- 79% of users significantly reduced their consumption of drugs
- 2 out of 3 tension headaches are halted by Cefaly’s programme 1
- 65% reduction of head pain sensitivity after 20 minutes of treatment with Cefaly
- 66% reduction in pain severity after 20 – 40 minutes of treatment with Cefaly’s programme 1
- 59% reduction in the frequency and duration of painful episodes
- 1 in 4 migraine attacks are controlled by Cefaly’s programme 1
Cefaly is a medical device with medical CE mark under the European Medical Devices Directive MDD 93/42/EEC.
How does Cefaly work?
The majority of headaches and migraines project pain into forehead and front part of the scull. This area is innervated by the upper branch of the trigeminal nerve – the ophthalmic nerve called the Willis’ nerve and its subranches, the supra-trochlear and supra-orbital nerves. Cefaly generates gentle electric impulses that act on the nerve cells and influence the nerves affected by pain. Namely, Cefaly works on nerves responsible for the pain and other sensations in the facial area. Cefaly’s electrode covers the centre of the forehead and establishes contact between the nerves innervating the area. Consequently, Cefaly acts on all the nerves in the area that is most associated with migraines and headaches. Through its electrode, Cefaly transmits specific electrical impulses designed to influence the trigeminal nerve utilising two important mechanisms of action specifically typical to TENS therapy - endogenous endorphin production and pain gateway control:
1. Endorphin production mechanism
Cefaly programme stimulates the endorphin producing nerve fibres of the trigeminal nerve, thus increasing the production of endogenous endorphins. Endorphins are neuro-hormones that induce the feeling of wellbeing. Higher levels of endorphins alter the headache’s or migraine’s trigger threshold level and reduce the number of attacks.
2. TENS mechanism – the ‘gateway control’
One of the Cefaly’s programmes stimulates the touch sensitivity fibres of the trigeminal nerve with high frequency stimuli and partially blocks the entry of the pain into the nervous system. This mechanism is called the gateway control system. You can easily imagine that partially blocked entry gate stops the pain signals from entering the nerve pathway that would normally take them to the pain centre in the central nervous system. When pain signals do not reach the brain, no pain can be felt.
Cefaly utilises proven TENS technology to treat migraines and headaches.
TENS stands for Transcutaneous Electrical Nerve Stimulation. TENS therapy is well recognised for its efficacy, safety and absence of side effects.
Cefaly is harmless and very safe to use. Its safety has been demonstrated in test and clinical studies. There are no adverse side effects.
Cefaly generates very precise electrical impulses and stimulate the nerve fibres selectively. As the impulses are generated very slowly, they are virtually imperceptible at the start of the treatment session. The advanced technology in Cefaly enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of individual users for personalised efficacy and comfort.
Using Cefaly Anti-Migraine TENS
Cefaly is simple to use. It is worn like a pair of spectacles or a forehead band.
- Firstly you place the self adhesive reusable Cefaly electrode on your forehead. Then you position the Cefaly unit over the electrode on your forehead so that the unit connects with the electrode. When you press the button on the device, Cefaly will commence the 20 minute treatment and deliver it automatically. For the 20 minutes duration of the treatment, you can either relax or carry on with the task in hand as normal. Please note that you must not use Cefaly when driving. When the treatment finishes, remove Cefaly unit from your forehead and then remove the skin electrode.
- During the session, you will feel pleasant tingling sensation. You can adjust the intensity of this sensation to your personal preference. After the treatment session you can either place Cefaly and the electrode into storage in its holder or start another session immediately, if appropriate.
- After the session you may feel localised tickling sensation on your forehead. A pleasant sensation of lightness and coolness felt over your forehead extends to the whole of your face and may last for several hours. You will have a deep feeling of rest and relaxation with an anti-stress effect. A very intense sense of wellbeing envelopes you body as the Cefaly treatment is the most effective way of increasing natural endorphin production, giving you a profound sense of general wellbeing.
Who can use Cefaly Cranial TENS
- Headaches affect people of all ages. Cefaly acts on physiological mechanisms that are not age dependent. Cefaly can therefore help to alleviate the symptoms or prevent them from arising regardless of your age. Cefaly is suitable for children from the age 8 and over, but the children should always use Cefaly under adult supervision.
- You should read Cefaly manual thoroughly prior to first use and refer to it regularly thereafter.
- Please note that if you experience an unusual and sudden acute headache, do not use Cefaly, but seek immediate medical advice.
Cefaly Transcutaneous Electrical Stimulator of Supraorbital Nerve - indications
Cefaly is designed to prevent and treat chronic and recurrent headaches. Cefaly is also able to substantially reduce or prevent stress and stress related anxiety.
Cefaly is beneficial, when the pain is located in the front half or the skull. There are no proven benefits, when the pain is located at the back of the skull or in the lower part of the face below the eyes.
Cefaly has 3 pre-set programmes
- Programme 1 is designed to treat an acute attack. Programme 1 is set to generate very hign frequency impulses that stimulate the tactile sensitivity of the Aβ nerve fibre. Stimulation of these fibres blocks the pain messages and prevents them from reaching the brain. Cefaly is applied, when the pain is already present. It may be repeated several times in succession as required.
- Programme 2 is designed to act prophylactically. Programme 2 generates low frequency impulses that stimulate the nerve fibres that are known as ‘discriminative pain’ fibres. Stimulation of these fibres increases endorphin production. Released endorphins induce general relaxation and a feeling of wellbeing.
- Programme 3 has anti-stress effect and can also be used effectively to prevent tension headaches caused by stress. Programme 3 is designed to induce a great sense of wellbeing and relaxation or to treat stress and anxiety. Programme 3 can be used, when there is a specific need for you to relax or to treat an episode of stress. Programme 3 can also be used regularly for at least 3 times per week to reduce chronic stress or improve general health and wellbeing.
Cefaly and Headaches
There are many types of headaches arising from a variety of causes. Here we focus on the most common types:
- Tension headache
- Cluster headache
- Trigeminal neuralgia
Cefaly and Tension Headache
Tension headache is the most common type of headache that occurs in up to 30 % of population and in both men and women. Tension headache is triggered by stress and anxiety. Most people experience tension headache as pressure or tightness around the head. The frequency of tension headaches can be worsened by excessive or inappropriate use of pain killers. Cefaly presents an effective way to treat tension headache and enables reduction in the consumption or even total discontinuation of pain killer intake.
You may use Cefaly Programme 1 during an acute attack and repeat it in succession as required. You can also prevent further attacks by using Programme 2 for prophylaxis. For best results, Programme 2 is used once or twice a day for 6 to 16 weeks until significant reduction in the frequency and intensity of the attacks is achieved. Programme 3 should be used, when you wish to increase the anti stress and relaxing action of Cefaly to reduce your stress levels that lead to tension headaches.
User statistics: 93% of users found that Cefaly significantly reduced frequency of their tension headaches. 86% of users found that Cefaly significantly reduced severity of pain or entirely diminished their tension headaches.
Cefaly and Migraine
Migraine occurs in up to 12% of population and is much more common in women. The pain can be severe, pulsing and one sided. It can get further aggravated by physical exertion. Migraine is often accompanied by nausea, vomiting and sensitivity to light and noise. Sometimes migraine is preceded by an aura that is characterised by tingling sensation in specific areas of the body, visual disturbances and blind spots in the visual field. Visual problems experienced with migraine are referred to as ‘ophthalmic migraine’.
Migraines vary between people. They can occur frequently and each episode can have different duration from 4 to 72 hours. There are no symptoms experienced between attacks. Intensity and frequency of migraine attacks vary between people as well as their pattern changes in the sufferers’ life time.
There are many causes of migraine. The most common are stress and anxiety, trauma and excessive consumption of alcohol.
Frequent ingestion of large quantities of headache medication can exacerbate the condition and lead to a disabling form of migraine called ‘transformed migraine’. Transformed migraine presents with greater frequency and duration of attacks and can occur daily. Cefaly is particularly useful in reducing medication intake and can therefore help to prevent progression of the condition to the disabling transformation migraine.
You can use Cefaly Programme 1 to treat acute migraine attack. You can treat the attack repeatedly several times on the Programme 1. Alternatively, you can also use Cefaly Programme 2 as a prophylaxis. Programme 2 increases endogenous endorphin production. High levels of endorphins help to fight the main causes of migraine development. For best results, Programme 2 is used once or twice a day for 6 to 16 weeks until significant reduction in the frequency and intensity of the attacks is achieved.
User statistics: 47% of users experienced reduction in frequency of attacks with 52% reduction in pain severity
Cefaly and Cluster Headache
Cluster headaches are less common than migraines. Cluster headache means ‘grouped’ headache as the attacks repeat closely. Cluster headache occurs in approximately 1% of population and affects more men than women. The pain is one sided and occurs always on the same side of the head in the orbital and Supraorbital region. Normally at the same time the sufferer also experiences a blood shot watery eye and a blocked nose.
Repeated attacks are grouped closely together over a period of several weeks and the pain often strikes on daily basis or even few times per day. Each attack lasts between 20 minutes and two hours. The attacks cease after several weeks, giving a pain free period that can last for several months or even years.
Cefaly is perfect for prevention of cluster headaches. Cefaly’s Programme 1 is effective during the acute attacks and can be applied repeatedly until the attack is over.
User statistics: 67% of users found that pain intensity associated with cluster headaches was lessened significantly. 37% of users found that length of cluster headaches attacks was significantly reduced.
Cefaly and Frontal Sinusitis
Cefaly may be beneficial in the management of the symptoms of sinusitis. It needs to be emphasised that Cefaly will only treat the symptoms rather than the cause. Cefaly’s Programme 1 will alleviate the sensation of pain and dull headache and can be applied as frequently as required. Medication prescribed or recommended by a doctor must be taken.
User statistics: 100% of users experienced significant improvements in symptoms.
Cefaly and Trigeminal Neuralgia
Trigeminal nerve innervates the entire face and front half of the skull. Cefaly acts only on the ophthalmic branch of the trigeminal nerve.
Idiopathic trigeminal neuralgia – the sufferer experiences severe stabbing pain that lasts less than a minute. This type of neuralgia normally occurs in the face below the eyes in the area not controlled by the ophthalmic nerve, hence cannot be treated with Cefaly. However, in some rare cases, this type of neuralgia affects the area controlled by the ophthalmic nerve – in the eye socket and front half of the skull. When such neuralgia in the area covered by the ophthalmic nerve occurs, Cefaly may be of benefit. Programme 1 can substantially reduce nervous excitability and reduce the frequency of the attacks.
Symptomatic trigeminal neuralgia – occurs when one or several branches of the trigeminal nerve is injured or inflamed due to a variety of reasons, such as vascular malformation, tumour, trauma or inflammation, etc. Cefaly can be helpful in such cases and will treat the symptoms of nerve pain effectively, if the pain is located in the area innerved by ophthalmic nerve, such as eye socket or forehead or the front half of the skull. Cefaly’s Programme 1 can be used as frequently as required alongside of prescribed medical treatment that aims to reduce or reverse the cause of this neuralgia.
Cefaly Cranial TENS Contraindications: You should not use Cefaly after recent brain or facial trauma; if you suffer with Meniere’s disease; if you have broken or damaged skin on your forehead in the area of electrode application.
Cefaly Cranial TENS Precautions: You should not use Cefaly while driving or operating heavy industrial machinery.
UK Shipping Schedule and Costs
UK delivery speed and cost are selectable in the Checkout. All orders are shipped in plain discreet packaging.
- UK Regular Delivery (£4.00 + VAT):
Delivery in 2 - 3 working days. Orders must be received before 2 pm (Monday – Friday).
- UK Next Day by Courier (£7.00 + VAT):
Next Day Delivery by Courier for orders received before 2 pm on working days (Monday to Friday) - expect delivery on next working day (Monday to Friday).
- UK Free Delivery (free):
UK Free Delivery is free and takes approximately 5 - 6 working days. Purchases shipped with Free Delivery cannot be tracked!
- UK Saturday Delivery (£12.50 + VAT):
Saturday Delivery applies only to the UK Mainland Only. Saturday Delivery Orders must be placed before 2 pm on the Friday. Orders received after 2 pm on Friday will be delivered on Saturday next week.
Overseas Shipping Schedule
- Overseas deliveries take approximately 7 - 14 working days depending on destination.
- Shipping costs depend on the type of goods and the delivery address.
- Cost of shipping is shown in the Checkout prior to the completion of the purchase.
- VAT is removed automatically from all purchases for deliveries outside the EU.
- Customs Fees or Import Duties may be charged in the country of destination outside the EU. If such charges apply, they are the customer’s responsibility. Custom Fees or Import Duties do not apply to deliveries to EU countries.
One universal size headband.
Cefaly Cranial TENS is supplied with a carry case, fitted batteries (2 x 1.5V AAA alkaline batteries), skin electrode, cleansing wipes and User Manual. CE mark Class 2a Medical Device (CE0499). 2 years warranty.
Cefaly electrodes are supplied in packs of 3.
VAT exemption is available, when purchased for personal use by people with relevant chronic conditions. VAT relief declaration must be completed online at the time of purchase.