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