Cefaly

Q. What is Cefaly?

Cefaly is a novel medical device that makes use of advanced TENS (Transcutaneous Electrical Nerve Stimulation) therapy which has been used in medical circles for over 40 years and is well recognized for its efficacy, safety and absence of side effects to prevent pain signals from reaching the brain.

Cefaly is an extremely simple to use device and is being found to be highly effective for people suffering from migraines and cluster/tension headaches, as well as for people suffering from trigeminal neuralgia and frontal sinusitis.

Q. How does Cefaly work?

Cefaly generates gentle electric impulses that act on the nerve cells and influence the nerves affected by pain. The main nerve in the head that is involved in headaches is known as the trigeminal nerve. Through an electrode, Cefaly transmits impulses that are extremely specific and perfectly adapted to the trigeminal nerve.

Cefaly acts on the nervous system via two principal mechanisms:

Endorphin-producing mechanism:A Cefaly programme stimulates the endorphin-producing nerve fibres (Aδ) of the trigeminal nerve, which increases their production. The endorphins are the neuro-hormones that give a feeling of wellbeing. With a higher level of endorphins, the trigger threshold for a headache or migraine is altered, and there are therefore fewer such attacks.

TENS mechanism:One of the Cefaly programmes stimulates the touch sensitivity fibres of the trigeminal nerve at high frequency, partially blocking the entry of pain into the nervous system.

For a detailed explanation of the method behind Cefaly’s groundbreaking design, click here.

Q. Why Cefaly?

Numerous tests and clinical studies bear witness to Cefaly’s impressive effectiveness in following scenarios:

• For prevention: A prevention programme increases the production of endorphins and raises the trigger threshold of the pain. The result: attacks are less frequent.
• To stop drugs: With no side-effects, Cefaly can replace or considerably reduce the consumption of painkilling medication.
• For relief: An ‘attack’ programme blocks pain and provides relief during attacks.
• To fight against stress: An anti-stress programme produces general relaxation and a strong sense of well-being.

The treatment itself is to be carried out for 20 minutes a day on a daily basis. Clinical trials have concluded:

• 93% reduction in tension headaches when Cefaly was used for 20 minutes daily, for a 30 day period.
• 86% reduction in frontal sinusitis when the Cefaly was used for 20-40 minute daily.
• 67% reduction in pain, and 37% of complete reduction in attacks of cluster headaches when the Cefaly was used for a 20-120 minute single session.
• 47% reduction of migraines when the Cefaly was used for 20 minutes daily for 15 days.
• A 20-60 minute session left patients feeling that overall pain was reduced by 52%.

Q. How do I use Cefaly Electro Therapy?

The innovative product is straight forward, lightweight and extremely cost effective. Its self adhesive electrode is placed directly on to the forehead. The Cefaly device is worn like a pair of spectacles, and once in position, connects to the electrode. For a full detailed step by step guide on how to use Cefaly, click here.

Q. Is it safe to use Cefaly?

Cefaly is a patented medical device supported by numerous clinical studies and safety tests. Cefaly was clinically studied over 5 years in pain clinics at university hospitals and in specialist laboratories.

Cefaly was designed and developed in line with a strict risk analysis compliant with international standard ISO 14971 applicable to medical equipment. Cefaly is a patented system and bears the CE medical mark. Cefaly complies with directive 93/42/EEC pertaining to medical devices and with all associated international IEC standards.

Q. Are there any side effects of Cefaly?

All the substances and materials used are bio-compatible and have been subjected to skin testing. No clinical studies carried out with Cefaly have revealed any evidence of side effects or problems. Several million treatments with Cefaly have been monitored and no problems or side effects were reported.

Children from 8 years can use Cefaly under the supervision of an adult. Cefaly can also be used by pregnant women without risk.

Precautions:

The only precautions and notable side-effects are as follows:

• Do not use Cefaly whilst driving.
• Redness of the skin in the area around the electrode may persist for a few minutes after the session has ended.

Counter-Indications:

• Recent brain or facial trauma
• Skin abrasion on the forehead in the area of application of the electrode
• Meniere's disease

Q. What comes with the Cefaly Kit?

Cefaly is supplied with:

• Carry case,
• 2 x 1.5 V AAA alkaline batteries,
• Skin electrode
• Cleansing wipes
• User manual