BrainCool-Migraine
Research type
Research Study
Full title
Nasal Cavity cooling for the symptomatic relief of migraine headache – A randomized, double blind, placebo controlled study - BrainCool-Migraine study
IRAS ID
218563
Contact name
Jitka Vanderpol
Contact email
Sponsor organisation
Braincool AB
Duration of Study in the UK
1 years, 8 months, 30 days
Research 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. It will involve using two nasal catheters to spray a mixture of compressed air and evaporative coolant into the nasal cavity (active device) which provides localised cooling via evaporation, conduction and convection 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. The placebo device will spray compressed air only into the nose with very minimal cooling effect. In total, 90 patients randomised in a 1:1 fashion 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 2 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.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0029
Date of REC Opinion
27 Feb 2017
REC opinion
Further Information Favourable Opinion