Cefaly® Dual Trigeminal Neurostimulator for Acute and Preventive Migraine Treatments
Cefaly® Dual is an External Trigeminal Neurostimulator indicated for migraine treatments. Cefaly® Dual features 2 pre-treatment settings – one high frequency Acute setting treats acute episodes of migraine and the second low frequency Prophylactic setting aims to reduce the frequency of attacks.
Cefaly® treatment is proven effective and safe and Cefaly® Dual can be used as the first line treatment for headaches and migraines or alongside other conventional treatments. Cefaly® Dual’s neurostimulation treatments are drug-free and therefore can considerably reduce consumption of pain killers, thus reducing the risks of drug-related side-effects.
Cefaly® Dual is rechargeable for convenience and long-term economy and practicality.
How does Cefaly® Dual work
Using a self-adhesive forehead electrode to bilaterally connect with the upper branches of the trigeminal nerve system, the Cefaly® Dual generates electric pulses and transmits them through the surface of the skin to the branch V1 of the trigeminal nerve (i.e. specifically the supraorbital nerve) to combat pain and discomfort of headaches and migraines.
Cefaly® Dual has only 2 programmes and is simple to use.
- Programme 1 for Acute migraine attacks
Programme 1 is a high frequency setting that is designed to induce a sedative calming effects on the nervous system at the root of the migraine attack. This leads to pain relief. You can apply Cefaly® Dual, when the migraine is already present, however, if possible, it is best to apply Cefaly® at the first signs of the forthcoming migraine attack.
Pressing the central start button on the Cefaly® ® Dual once activates the Programme 1. Programme 1 takes 60 minutes to complete. The intensity increases automatically during the treatment duration. It begins with very weak signals and progressively increases and reduces at the end of the programme duration. If intensity becomes too much, you can reduce it manually by pressing the central button once to stabilise the signals.
- Programme 2 for Prophylaxis
Programme 2 is a low frequency setting that aims to reduce frequency of attacks. Designed to prevent migraine, the Programme 2 should be used during the migraine-free intervals between acute attacks, when you do not suffer migraine -related painful headache.
Pressing the central button on the Cefaly® Dual twice activates Programme 2. Programme 2 takes just 20 minutes to complete and the device stops automatically upon completion of the duration. Intensity grows from the start going forwards and subsides towards the end. If intensity becomes too much for you to bear, you can reduce it manually by pressing the central button once to stabilise the signals.
Please note that for the treatment to be effective, it is best to use the highest intensity possible. After several sessions, you will become fully accustom to the sensation caused by the stimulation and will be able to tolerate it better.
Stimulation of the trigeminal nerve has sedating and calming effects. During regular use of Cefaly® ® Dual for prevention of migraines, the sedative effects of the trigeminal nerve stimulation help to reduce the number of acute migraine attacks.
Using Cefaly® Dual step by step
- Ensure that your Cefaly® Dual is fully charged
- Ensure that your forehead is free of make-up, clean and dry
- Wipe the skin on your forehead between eyebrows with the Cefaly® Prepare wipe (provided)
- Remove the self-adhesive electrode from its plastic support and position it correctly on your forehead with the pointed part facing downward
- Ensure that the electrode fully and smoothly adheres to your skin
- Fix the Cefaly® Dual unit on the electrode – 2 magnets hold the unit to the electrode, facilitating automatic correct positioning
- Select the programme by pressing the central button on the unit – once for Programme 1 for Acute attack (60 minutes duration) and twice for Programme 2 for Prophylaxis (20 minutes duration)
- To stop the programme before its end, simply pull the unit forward off the electrode – this disconnects the device and interrupts the session
- If you wish to continue/repeat the treatment after the one is completed, simply press the central button once within 30 seconds upon completion of the previous session, when you feel the intensity gradually subsiding – this action activates Cefaly® Dual to start a new session of the same programme immediately
- After you have completed your treatment, remove the device from the electrode by pulling it forward and then detach the self-adhesive electrode from your forehead and place it back on the plastic support for storage
- Wipe your forehead of any residues
The illustrated user manual is easy to understand and provides a good background to understanding Cefaly® Dual and how to use it for best results. The manual 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 treatment programme for different migraine needs, optimum frequency of treatments to achieve best results and what to expect long term.
During Cefaly® treatments, you can carry on with your normal daily activities or relax for the duration of the sessions. After completion of the treatment session, the Cefaly® switches off automatically and you should remove it by pulling it from your forehead. User manual also gives instruction on how to look after your Cefaly® Dual, clean it, store it and recharge it.
Cefaly® Dual Accreditation
Cefaly® Dual is a patented model and is protected by an international patent. Cefaly® ® is a registered international trademark.
Cefaly® Dual is a medical device, compliant with MDD 93/42/EEC (CE 0459). Cefaly® Dual carries 2 years warranty.
Cefaly® Dual technical specifications
- Operating conditions: +10° C to + 35° C; 30 – 75% RH; 700 hPa to 1060 hPa
- Transport / Storage conditions: - 5° C to + 35° C; 45 – 75% RH; 500 hPa to 1060 hPa
- Case: PC plastic, painted
- Dimensions: 55 x 40 x 15 mm
- Weight: 12 g
- Electrical specifications for a charge between 0 – 1000 ohms
- Constant amplitude intensity – predefined automatically, depending on the programme
- Rectangular impulses
- Compensated constant current preventing any galvanic direct component
Stimulation parameters for Programme 1 and Programme 2:
- Maximum intensity: P 1: 16 mA; P 2: 16 mA
- Pulse frequency: P 1: 100 Hz; P 2: 60 Hz
- Pulse width: P 1: 250 µs; P 2: 250 µs
- Pulse duration: 500 µs; P 2: 500 µs
- Session duration: P 1: 60 minutes; P 2:20 minutes
- Maximum quantity of electricity per impulse: 5 µC
- Maximum rise time of an impulse: 5 µs at 50% of the maximum
- Number of programmes: 2
- Device service life: 7 years
- Charging system service life: 7 years
- Electrode shelf life: electrode lasts circa 20 utilisations
Precautions and Contraindications
- Do not use Cefaly® Dual while driving or during activities requiring focus and alertness
- In the hours after Cefaly® Dual treatment, do not drive or operate machinery or perform activities requiring alertness and focus
- Do not use on any other areas than the forehead
- Can be used on children from age 8 under adult supervision
- Cefaly® Dual is for use on persons from age 15 onwards
- Do not use after recent brain or facial trauma (less than 3 months)
- Do not use, if suffering abrasions in the electrode application area on the forehead
- Do not use, if suffering with allergy to acrylate
- Do not use, if suffering with cutaneous hypersensitivity of the forehead skin
- Do not use in the presence of electronic implants in the head
- Do not use, if suffering with ophthalmic shingles
- Do not use, if suffering with trigeminal neuralgia
Cefaly® 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
- 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
- Always read user manual prior to first use and retain user manual for future reference
- Consult your doctor, if in any doubt about using Cefaly® Dual
Summary of Cefaly® evidence
An important clinical study on acute migraine therapy treated with the Cefaly® medical device was published in the peer-reviewed medical journal of the International Headache Society, Caphalalgia. The results of the study, in short known as ACME (ACute Migraine therapy with External trigeminal neurostimulation), prove the efficacy of the Cefaly® in treating migraine attacks. After one hour of the Cefaly® acute treatment, 29% of patients were pain-free and 79% achieved significant pain relief. Dr Pierre Rigaux, the CEO of Cefaly Technology said: "We now have an efficacy similar to triptans, which have long been considered the most effective drugs for acute migraine but without the risks and side effects. It is unique to have a non-invasive, non-drug, treatment that is as effective, if not better, than medication intended for migraine.” Click here to read ACME study.
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® Dual – your perfect drug-free solution to headaches and migraines - safe and effective way to live a migraine-free life.
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 (£5.00 + 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 £50.00 excluding VAT or more:
UK Free Delivery Option for online only orders of £50.00 excluding VAT or more is free and takes approximately 3 - 4 working days. Purchases shipped with Free Delivery cannot be tracked!
- UK Saturday Delivery (£15.00 + 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 40 x 15 mm / Weight: 12 g
- Cefaly® Dual kit consists of the Cefaly® Dual unit, 1 reusable self-adhesive Cefaly® electrode, power adapter fitted with 3 pin UK plug, expendable USB cable, 5 x wet skin wipes sachets, user manual and carry case. CE 0459 and 2 years warranty.
- Cefaly® Skin Electrodes - a pack of 3 individually sealed replacement electrodes.
- Cefaly® Hypoallergenic (Blue) Skin Electrodes - a pack of 3 individually sealed hypoallergenic electrodes.
Please note – the above electrodes are compatible with the Cefaly® Dual and Cefaly 2 (previous model).
VAT exemption available to people suffering with chronic headaches and migraines. VAT declaration must be completed at the time of purchase on online.