Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - A Randomized, Double Blind, Placebo Controlled Study" , the BrainCool-Migraine Study

Detailed Summary

This study will be a randomised placebo controlled trial examining the effectiveness of using an intranasal evaporative cooling device (the RhinoChill intransal device) in providing relief of pain and symptoms of acute migraine.The treatment works by introducing cooling into the passageways of the nose through two small cannulas thereby cooling the local nasal tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict as well as stimulating special cold receptors that are thought to be involved in the relief of migraine, thereby providing both pain and associated symptomatic relief. In total, 90 patients randomised in a 1:1 fashio n will be recruited from three different NHS Trusts. The patients will have a 30-day period of data collection for their current migraine frequency, treatment and response to medication (with a minimum of 2 migraine attacks recorded) before starting the treatment phase with the RhinoChill Device. Treatment will be for 3 migraine attacks. Only a single treatment is allowed for the first attack, but on the second attack the patient may deliver 2 treatments with a gap of at least 2 hours between treatments, if indicated.

Study Details

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Interventions