Information for the public

Benefits and risks

Benefits and risks

When NICE looked at the evidence, it decided that there was not enough evidence about how well the procedure works. The 3 studies and 1 adverse event report that NICE looked at involved a total of 2,405 patients. But only 2 studies, involving 87 patients, looked at how well the procedure works.

Generally, the 2 studies showed the following benefits after 3 months of treatment with the device:

  • fewer days with migraine

  • fewer migraine attacks each month

  • fewer days each month with any headache

  • less severe headaches

  • fewer migraine drugs needed each month

  • most patients were very or moderately satisfied.

The studies showed that the risks were not serious and were seen in a small number of patients. They included:

  • 'minor and reversible events' (no further details provided) in 4% of patients

  • local pain or intolerance to pins and needles caused by the device in 2% of patients

  • skin problems in less than 1% of patients, including temporary local skin allergy, forehead skin irritation and a feeling of bruising on the forehead

  • muscle weakness and dizziness in 1 patient, which went away within 2 hours after the device was stopped.

NICE was also told about some other possible risks: abnormal sensitivity to pain, sleepiness and local discomfort.

If you want to know more about the studies, see the guidance. Ask your health professional to explain anything you don't understand.

  • Information Standard