|Cefaly 2 Migraine Treatment leaflet||821.47 KB|
|User Safety and Satisfaction Information||807.97 KB|
|Supraorbital Nerve Stimulation study||644 KB|
|Transcutaneous Supraorbital Nerve Stimulation study||724.37 KB|
Cefaly 2 Transcutaneous Electrical Anti-Migraine Neurostimulator
Cefaly 2 Transcutaneous Electrical Stimulator of Supraorbital Nerve
Cefaly 2 is the new model of the Cefaly Anti-Migraine Stimulator, now referred to as Cefaly 1.
Cefaly 2 is indicated for the treatment of acute attacks and long-term prevention of migraines.
Cefaly 2 is an external stimulator of the supraorbital nerve. Supraorbital nerve (also referred to as the frontal nerve) is a branch of the trigeminal nerve. Supraorbital nerve provides sensory innervation to the forehead, upper eyelids and frontal parts of the scalp. Cefaly 2 is, therefore, an external trigeminal nerve stimulator.
Cefaly 2 differs from the original Cefaly device as it uses only a single self-adhesive electrode placed on the forehead instead of the electrode holding headband in case of the original Cefaly model. Cefaly 2 is powered by a rechargeable 3.7 V lithium-ion battery and can be quickly recharged using cable and adapter provided.
For the duration of the treatment, the self-adhesive Cefaly skin electrode is placed on the forehead to bilaterally connect with the upper branches of the trigeminal nerve (i.e. supraorbital nerve). When switched on, Cefaly generates electric pulses and transmits them through the surface of the skin to the branch of trigeminal nerve (i.e. specifically the supraorbital nerve) to combat pain and discomfort of headaches and migraines.
Cefaly is proven effective and safe and can be used as the first line treatment for headaches and migraines. Cefaly treatment is drug free and the use of Cefaly can considerably reduce consumption of pain killers and therefore reduce the side-effects associated with pain killers.
Cefaly treatment is simple, well accepted and well tolerated. Data collected from 14745 migraine sufferers using Cefaly for more than 3 months suggests a high compliance of 72.4%, suggesting higher adherence to Cefaly treatments than to oral migraine preventive drug treatments.
- 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
- 1 in 4 migraine attacks are controlled by Cefaly’s programme 1
- 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
In June 2016, the National Institute for Clinical Excellence (NICE) issued guidelines for the NHS clinicians wishing to use Cefaly in their practice. You can view the summary of the NICE Guidelines for Cefaly announcement on this page below – just click on the link.
Using the Cefaly 2 Anti-Migraine Stimulator
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 migraines and headaches. The treatment has powerful anti-stress effects, inducing wonderful feeling of wellbeing and relaxation.
Cefaly 2 is easy to use and features 3 pre-set programs:
- Program 1 is designed to treat migraine attacks. Duration: 20 minutes.
- Program 2 is a preventive program designed to prevent migraines. Program 2 should be used during pain-free times. Duration: 20 minutes.
- Program 3 is gentler and softer than the other programs. It is designed as a substitute to program 1 and 2 during time required for you to get accustomed to Cefaly stimulation. Duration: 20 minutes.
Intensity of treatments can be adjusted down, but for the best outcomes, it is recommended that you use the highest intensity possible. The sensation of the stimulation may feel a little strange to begin with, but after few sessions, you will become fully accustom to. Majority of the users can tolerate the maximum intensity stimulation for the duration of the 20-minute treatments after just few initial sessions.
Stimulation of the trigeminal nerve (i.e. supraorbital nerve, the upper branch of trigeminal nerve) has calming and sedating effects. During regular use of Cefaly 2, the sedative effects of the treatments help to reduce the number of migraine attacks.
The illustrated user manual is easy to understand and provides a good background to understanding Cefaly and how to use it for best results. The manual also gives step by step instructions for correct placement of Cefaly electrode, description of sensation induced by the Cefaly, how to carry out the treatments, including the best choice of programs for different migraine needs, optimum frequency of treatments for best results and what to expect from Cefaly treatments.
When using Cefaly, you can carry on with your normal daily activities or relax for the duration of the 20-minute session. After completion of the treatment session, the Cefaly switches off automatically. You can remove Cefaly easily from your forehead by pulling it off.
The user manual also gives instruction on how to look after your Cefaly 2, including cleaning, storage and recharging.
Cefaly 2 Transcutaneous Electrical Stimulator of Supraorbital Nerve is a patented medical device, compliant with MDD 93/42/EEC (CE 0459). Cefaly 2 carries 2 years warranty.
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 still 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.
Summary of Cefaly evidence key points
- A multicentre double-blind randomised controlled trial (RCT) of 67 patients with migraine compared transcutaneous supraorbital neurostimulation (tSNS; n=34) against sham treatment (n=33). In the intention-to-treat analysis, there was a statistically significant decrease in the mean number of migraine days between baseline and 3 months after treatment in the tSNS group (6.94±3.04 to 4.88±3.46; p=0.023), but not in the sham group (6.54±2.61 to 6.22±2.99; p=0.608). The difference between the 2 groups was not statistically significant (p=0.054). A case series of 20 patients with migraine without aura reported a statistically significant decrease in the frequency of migraine days per month from 4.5±0.24 at baseline to 2.06±0.28 at 60-day follow-up (p<0.001).
- In the RCT of 67 patients the 50% responder rate (defined as the percentage of patients having a greater than 50% reduction in monthly migraine days) was statistically significantly higher in the tSNS group than in the sham group (38% [n=13] versus 12% [n=4]; p=0.023) in the intention to treat analysis. The percentage of patients with at least a 25% reduction (moderate improvement) in migraine days was also statistically significantly higher in the tSNS group than in the sham group (59% [n=20] versus 27% [n=9], p=0.014). The case series of 20 patients reported a 50% reduction in monthly migraine attacks and migraine days in 81% and 75% of patients respectively at 60-day follow-up.
- In the RCT of 67 patients (intention-to-treat analysis) the monthly migraine attack frequency was 4.37±1.87 at baseline and 3.55±2.94 at 3 months (p=0.058) in the tSNS group, and 4.04±1.52 at baseline and 3.89±1.89 at 3 months (p=0.516) in the sham group. The difference between the 2 groups was statistically significant (p=0.044).
- In the RCT of 67 patients (intention-to-treat analysis) there was a statistically significant decrease in monthly days with any headache between baseline and 3 months after treatment in the tSNS group (7.78±4.00 to 5.27±3.55; p=0.011), but not in the sham group (6.72±2.63 to 6.49±3.20; p=0.674). The difference between the 2 groups was statistically significant (p=0.041).
- In the RCT of 67 patients (intention-to-treat analysis) the mean headache severity per migraine day (on a 4-point scale, 0 indicating no pain and 3 indicating severe pain prohibiting daily activities) was 1.96±0.46 at baseline and 1.8±0.60 at 3 months (p=0.131) in the tSNS group, and 1.78±0.41 at baseline and 1.73±0.53 at 3 months (p=0.443) in the sham group. The difference between the 2 groups was not statistically significant (p=0.301). In the case series of 20 patients there was a statistically significant reduction in average pain intensity (measured on a visual analogue scale from 0–10, 0 indicating no pain and 10 indicating severe pain) during migraine attacks, from 8.0±0.1 at baseline to 6.7±0.2 at 60-day follow-up (p=0.002).
- In the RCT of 67 patients (intention-to-treat analysis) there was a statistically significant decrease in the monthly intake of migraine drugs for acute attacks in the tSNS group (11.45±8.35 to 7.25±7.31; p=0.0057), but not in the sham group (9.24±4.75 to 9.28±5.69; p=0.822). The difference between the 2 groups was statistically significant (p=0.0072). In the case series of 20 patients, there was a statistically significant reduction in the use of rescue drugs from 5.6±0.4 medications at baseline to 2.2±0.3 at 60 days follow up (p<0.001). Statistically significant reductions were also seen in the intake of non-steroidal anti-inflammatory drugs, from 3.2±0.6 medications at baseline to 1.3±0.4 at 60 days follow up (p=0.02), and in triptans, from 2.4±0.7 medications at baseline to 0.9±0.3 at 60 day follow up (p=0.04).
- In the RCT of 67 patients the percentage of very or moderately satisfied patients was higher in the tSNS group (70%) than in the sham group (39%). The case series of 20 patients reported 100% satisfaction with tSNS treatment at 60 days follow up.
Cefaly 2 External Trigeminal Nerve Stimulator – your passport to migraine free life without drugs and drug related side-effects.
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 Option for online only orders of £40.00 excluding VAT or more:
UK Free Delivery Option for online only orders of £40.00 excluding VAT or more 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.
Dimensions: 55 x 46 x 15 mm / Weight: 12 g
- Cefaly 2 Stimulator kit includes Cefaly unit fitted with rechargeable lithium-ion battery, 1 x Cefaly skin electrode, 5 x skin wipes sachets, power adapter fitted with 3 pin UK plug, extendable USB cable, ‘first session with Cefaly’ guide, user manual and hard case carry bag. CE 0459 and 2 years warranty.
- Cefaly 2 Skin Electrodes - a pack of 3 individually sealed replacement electrodes.
- Cefaly 2 Hypoallergenic (Blue) Skin Electrodes - a pack of 3 individually sealed hypoallergenic electrodes.
VAT exemption is available, when purchased for personal use by people with relevant chronic conditions (i.e. diagnosed with migraine, chronic headaches, etc). VAT relief declaration must be completed online at the time of purchase.