VALENCIA, SPAIN – The day may be coming when physicians simply advise their patients experiencing migraine onset to “just chill.”
Literally.
A few minutes of intranasal evaporative cooling brought rapid improvement in headache pain and other migraine-associated symptoms, sustained for 24 hours, in 87% of patients in a small proof-of-concept study, Dr. Jitka Vanderpol reported at the International Headache Congress.
The novel migraine therapy, which also shows potential for treatment of cluster headaches, utilizes the same proprietary therapeutic hypothermia technology approved by European regulators as a method to increase neurologically intact survival after cardiac arrest. The RhinoChill technology, marketed by BeneChill International, utilizes an intranasal cooling catheter to deliver cooling. And it’s portable: The system weighs less than 5 kg, making it suitable for prehospital therapeutic cooling by first responders in cases of cardiac arrest.
While the current device is being used in the ongoing migraine studies, it’s bulkier and more powerful than necessary for this purpose, which doesn’t necessitate lowering core temperature. The company is developing a much smaller, more portable version specifically for treatment of headaches, explained Dr. Vanderpol, a neurologist at Cumbria Partnership National Health Service Foundation Trust in Penrith, England.
The proof-of-concept study involved 20 cryotherapy sessions in 15 patients. Participants were hospitalized for treatment so Dr. Vanderpol and coinvestigators could monitor its safety. The two efficacy endpoints were change from admission through 24 hours in headache pain scores on a 0-10 scale, and change in migraine-associated symptom severity, also self-rated on a 0-10 scale.
* Headache pain: From a mean baseline score of 5.96 at admission, scores improved significantly at every evaluation point: 4.28 after 5 minutes of intranasal cooling; 3.79 after 15 minutes of cooling, at which point treatment stopped; 3.12 immediately after treatment halted; 2.42 at 2 hours post-treatment; and 1.97 at 24 hours post-treatment.
* Migraine-associated symptom severity: From a mean score of 4.25 at baseline, scores dropped to 1.9 immediately after treatment, 0.9 at 2 hours, and 0.7 at 24 hours post-treatment.
Two hours post-treatment, 9 of 20 treatments had resulted in dual zero scores – that is, complete freedom both from headache pain and other migraine-associated symptoms. Another 9 of the 20 treatment applications provided partial improvement on both measures.
When patients were asked how intranasal cooling compared with their current rescue medications, 9 of the 15 rated intranasal cooling as superior, and 4 deemed it equal. There were no side effects in the study.
The cooling of the nasal passages and their associated blood vessels is achieved using medicinal air at a temperature of 2 degrees Celsius. Tympanic temperature didn’t change.
“We were not cooling the head, brain, or patient’s body,” Dr. Vanderpol said at the meeting sponsored by the International Headache Society and the American Headache Society.
In an interview, she cited several possible mechanisms of benefit.
One draws upon the neurovascular theory of migraine: Because of the configuration of vascular anatomy, cooled venous blood from the nasal and paranasal mucous membranes can flow to the dura matter. There is also some preliminary evidence to suggest cooling can affect certain calcitonin gene-related peptide receptors. In addition, cooling tissue results in reduced demand for adenosine triphosphate and oxygen.
The sphenopalatine ganglion is another possible site of action, although this would be more relevant for the treatment of cluster headaches, the neurologist added.
In an ongoing clinical trial, patients received instruction in use of the RhinoChill cooling device and were sent home with a loaner for self treatment. A large, definitive, randomized, controlled trial to confirm the therapeutic benefits and safety will be conducted once the mini-cooling system is available.
The pilot study received partial support from Benechill International in the form of loaner equipment and funding for a research nurse. Dr. Vanderpol reported having no financial conflicts.
bjancin@frontlinemedcom