Guidance
2 The technology
Technology
2.1 gammaCore (electroCore) is a non-invasive vagus nerve stimulator used to treat and prevent cluster headaches. It is self-administered by the person or their carer. After applying conductive gel, gammaCore is held against the neck (over the cervical branch of the vagus nerve) and delivers a small electric current for about 2 minutes. This stimulation should be repeated 3 times. The device is small and portable. gammaCore requires RFID (radio frequency identification) card activation which is renewed every 3 months (93 days). The RFID card activation allows gammaCore to deliver a maximum of 30 stimulations in each 24‑hour period. Conductive gel is provided with each new RFID card. Additional gel can be provided at no extra cost.
Innovative aspects
2.2 gammaCore is currently the only technology that uses non-invasive stimulation of the vagus nerve to treat cluster headache.
Intended use
2.3 The instructions for using gammaCore state that it should be used regularly throughout the day to prevent cluster headache attacks and acutely to reduce pain during an attack. gammaCore is intended to be self-administered, or treatment can be administered by a carer. Using gammaCore requires brief training and some manual dexterity. Training for patients and staff is provided by the company for free. gammaCore should not be used by people with an active implantable medical device, people with heart disease, during pregnancy or in children.
Costs
2.4 gammaCore is provided free of charge for the first 3 months (93 days). Subsequent treatment costs £625 for 93 days (excluding VAT).
For more details, see the website for gammaCore.