CoolHead system is a portable medical cooling device (CoolHead), designed for home-use by migraine patients. CoolHead will be based on BrainCool’s medical cooling concept of intra-nasal cooling by spraying a liquid coolant in the upper surface of the nasal cavity. CoolHead consists of a small, portable cooling system, and associated consumables: a vaporizing coolant and a nasal catheter that sprays the coolant into the nasal cavity.
Proof-of-concept and safety of intra-nasal cooling for migraine treatment has been initially demonstrated in a pilot study (CoolHead 1) using BrainCool’s RhinoChill device, demonstrating pain relief in 87% of patients with no significant side-effects.
Safety of this method of cooling has been established in the cardiac arrest population through its use for therapeutic hypothermia as neuroprotection. In the migraine population, the device is used at its lowest setting for a duration of 10-20 minutes (most clinical trial subjects used the device for 10 minutes per treatment).
BrainCool is currently undergoing two clinical studies in Europe. The first study (BrainCool Migraine Study), is a multi-center, double-blinded, randomized, placebo-controlled trial in 90 episodic migraine sufferers. Subjects in the active group are provided a CoolHead device to use at home and instructed to use it for 10 minutes as soon as possible after a migraine evolves.
In an additional clinical study (COOLHEAD 3), the device will be evaluated in 80 hospital in-patients who are admitted for treatment for medication overuse syndrome. These subjects will be evaluated and treated with CoolHead in a hospital setting. The primary endpoints are number of hours with a severe or moderate headache in the first seven days.