Medical devices

What are devices used for?

A lot of people want to use non-drug approaches to help manage their migraine symptoms. There are a range of medical devices which may be beneficial for headache or migraine symptoms. Below is an overview of the devices currently available in the UK.

Cefaly (external trigeminal nerve stimulation)

External Trigeminal Nerve Stimulation is delivered by the Cefaly device which is designed to prevent and treat migraine.

What is external trigeminal nerve stimulation?

Most headaches and migraine involve the trigeminal nerve. The trigeminal nerve is a nerve in the head, part of which runs around above your eye. This is the part of the trigeminal nerve that is stimulated by the Cefaly device.

An adhesive electrode is positioned on the forehead and Cefaly connects to this. Through the electrode, Cefaly generates precise micro-impulses in order to stimulate the nerve endings of the trigeminal nerve.

Neurostimulation of the trigeminal nerve with Cefaly aims to produce a sedative or calming effect. Regular repetition of this effect is thought to reduce the number of attacks of migraine.

Two studies, involving 87 patients, looked at how well the procedure works, and showed the benefits of reduced migraine after 3 months of treatment with the device.

NICE guidance

In May 2016 the National Institute for Health and Care Excellence (NICE) published guidance on the use of a transcutaneous electrical stimulation of the supraorbital nerve for treating and preventing migraine, in relation to the Cefaly device. NICE found that there were no major safety concerns, but the evidence for the effectiveness of Cefaly was limited. The NICE recommendation is that Cefaly should only be used with special arrangements for clinical governance, consent and audit or research. If you are interested in trying Cefaly, speak to your doctor initially.

Purchasing a Cefaly device

You can purchase Cefaly privately direct from the Cefaly website. If you try Cefaly, and after 60 days see no benefit you can use the ’60 day Cooling Off Period’. This means they will refund a proportion of the cost of the device, but retain a certain amount to cover the cost of safe disposal.

A study published by Cefaly showed a beneficial difference after two months so users should know if the device is helpful by that time. You can check the terms and conditions of the cooling off period before you purchase a device.

gammaCore (non-invasive vagus nerve stimulation)

gammaCore or nVNS is an approved treatment for cluster headache in the UK. It is a handheld device that is used to treat attacks when they occur, or as a daily preventive treatment. It uses set doses of non-invasive stimulation (nVNS), when held onto the skin to either the right or the left branches of the vagus nerve in the neck.

gammaCore Sapphire is the name of the device and it is rechargeable and reusable. It is activated on a regular basis (usually every three months) with a prescription. An authorised code is delivered to the device using a radio-frequency identification, or RFID, card.

gammaCore is CE-mark approved, meaning it meets the European safety, health, and environmental protection requirements.

How does it work?

gammaCore works by sending a mild electrical stimulation through the skin to activate the vagus nerve from outside your body. It is painless and the level of stimulation can be adjusted to what is comfortable.

Stimulation of the vagus nerve can relieve cluster attacks when they occur and some people also use it as a daily treatment to help prevent attacks.

Approval and Access

In December 2019, the National Institute for Health and Care Excellence (NICE) published guidance on the use of gammaCore and it has now been made available to treat cluster headache on the NHS.  It can only be prescribed by a specialist and is not available from your GP.

It is not available for migraine on the NHS. You can pay privately for gammaCore. You would need your specialist to complete the medical authorisation form. For more information about accessing gammaCore and the current cost contact electroCore at customerserviceuk@electrocore.com.

sTMS (single pulse transcranial magnetic stimulation for migraine)

sTMS is a non-invasive and non-drug treatment for migraine. It involves placing the sTMS device against the back of your head for a second to deliver a very brief pre-set magnetic pulse. The device is called sTMS mini. It is portable, rechargeable and reusable. It is activated on a regular basis (usually every 3 months) with a prescription.

sTMS mini is CE-mark approved, meaning it meets the European safety, health, and environmental protection requirements.

How does sTMS work?

The sTMS mini device is placed at the back of the head for less than a minute, generating a magnetic pulse that forms a mild electric current at the back of the brain. The number of pulses can be repeated as prescribed by your neurologist. The pulse is painless and generates mild currents in the brain tissue that are believed to interrupt the brain activity linked to migraine. sTMS is painless and causes no serious side effects.

Why choose sTMS

There are many reasons why you may want to use sTMS. These may include:

• if you already use medicines for other conditions and want to avoid drug interactions
• if you have other medical conditions such as heart disease and cannot take triptans and simple painkillers do not work for you
• If you want to cut back on painkillers
• personal preference such as women of child bearing age wishing to avoid medicines

sTMS scientific evidence

Evidence from clinical trials has shown that sTMS can reduce the severity and overall number of migraine attacks.  It has been used to treat migraine attacks when they occur and also daily to prevent attacks.

NICE approval

In January 2014 the National Institute for Health and Care Excellence (NICE) published guidance on transcranial magnetic stimulation for treating and preventing migraine.

NICE recommends that sTMS should only be used for the treatment of migraine under the care of a headache specialist.

Access to sTMS

sTMS is not currently available for migraine on the NHS. You can pay privately for this treatment, but you will need a prescription from your headache specialist. For more information, see the eNeura website or contact them at customercare@eneura.co.uk.

Nerivio (remote electrical neuromodulation)

Nerivio^® is a REN (Remote Electrical Neuromodulation) wearable device for migraine treatment and prevention that works safely and effectively by activating natural pain pathways to supress migraine and associated symptoms.

The Nerivio device is controlled by a smartphone app and is worn on the upper arm for 45 minutes every other day for prevention or as often as needed at the start of a migraine attack for acute treatment. During treatment, Nerivio stimulates nerves in the upper arm through Remote Electrical Neuromodulation (REN)—nerves that carry pain signals to the brain. This action triggers a pain-management response by the brain and works with the body to naturally turn off migraine pain without medications.

Nerivio is CE-mark approved, meaning it meets the European safety, health, and environmental protection requirements.

How does it work?

Nerivio^® uses Remote Electrical Neuromodulation (REN) to prevent and treat migraines. This innovative technology is delivered through a wearable device that stimulates the nerves to block migraine signals. Clinical trials have shown that Nerivio provides consistent relief from migraine pain and associated symptoms. It is safe, well-tolerated, and does not carry the risk of medication overuse headache.

Acute treatment – Use Nerivio as often as needed for 45 minutes to treat every migraine.

Preventive treatment – Use Nerivio as every other day for 45 minutes to prevent migraine.

Purchasing Nerivio

Nerivio can be provided on private prescription (please see your Health Care Professional for details), alternatively you can order via a guided questionnaire via Pharmacy 2U website.

For further information on Nerivio please visit www.nerivio.co.uk