Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study
Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study
The aim of the study is to evaluate the effect of self-administered intranasal cooling for
 the symptomatic relief of migraine headache and associated symptoms in an "at home setting".

 10-20 patients - who have been diagnosed according to the International Classification of
 Headache disorders (2nd Edition) criteria for Episodic migraine, with or without aura - will
 be included in the study.

 During a screening period of one month participants will record their migraine symptoms, any
 treatment and treatment effects. After a minimum om two migraine attacks the participants
 receive individual instructions on how to use the The RhinoChill® system. During the
 following treatment period of the study, participants are instructed to treat their upcoming
 three migraine attacks with 10 minutes of nasal cavity cooling according to the instructions
 and thereby register symptoms and treatment effects after 10 minutes, 1 hour, 2 hours, 24
 hours and 48 hours.
Mechanical techniques to alleviate migraine symptoms have been used for many years, cooling
 and compression being the most frequently applied. Cryotherapy is the most common
 non-pharmacological self-administered pain-relieving method currently used by migraine
 sufferers.

 The RhinoChill® System is a CE-Marked device that is currently commercially available in
 Europe. The RhinoChill® device is intended for temperature reduction in patients via the
 nasal cavity and can be used across a range of medical and surgical indications where
 reduction in patient temperature is required. The RhinoChill® system was originally designed
 specifically for use in the pre-hospital, in-hospital, in-clinic or other clinical settings
 for the induction of therapeutic hypothermia (reduction in brain and body temperature to
 between 32-34oC), in which other commercial cooling systems are not practical for use. The
 RhinoChill® system is portable and runs on batteries. The system cools by spraying an
 evaporative coolant into the nasal cavity via intranasal catheters. A previous study has
 shown that the use of RhinoChill® intranasal cooling within a clinic environment provided a
 statistically significant reduction of pain and associated symptoms of migraine at 5 and 10
 minutes (during treatment) and at 1 and 2 hours following treatment along with significant
 effect on pain and symptoms at 24 hours (all p values <0.001).

 The aim of the study is to evaluate the effect of intranasal cooling for the symptomatic
 relief of migraine headache and associated symptoms when the treatment is self-administered
 by the patient at home.

 The proposed study will be single group assignment with treatment self-administered by
 patients in their own home, with support and oversight from research support staff working
 under the direction of the investigators.

 The study process is as summarized:

 Participants will be identified through adverts at Lund University and are able to register
 interest via telephone or email. They are then contacted by a researcher by telephone for a
 brief eligibility check and to book a first meeting at the Braincool office.

 Meeting 1, at Braincool office (researcher and research support team):

 -  Eligibility check - stage one (Case Report Form 1)

 -  Trial information, viewing of device and catheter

 -  Informed Consent Form complete

 -  Instruction on how to register migraine attack symptoms and treatment effects in
 application/CRF2.

 Screening period starts. When the participant has registered two migraine attacks during the
 screeing period the next meeting is booked:

 Meeting 2, home visit (research support team):

 o Training on how to use the RhinoChill® device safely and how to register migraine symptoms
 and treatment effects in application/CRF 3

 During the following treatment period of the study, participants are instructed to treat
 their upcoming three migraine attacks with 10 minutes of nasal cavity cooling according to
 the instructions and thereby register symptoms and treatment effects after 10 minutes, 1
 hour, 2 hours, 24 hours and 48 hours.

 When the participant has used the RhinoChill® device to treat three episodes of migraine, or
 a duration of 3 months post-study has passed, the final meeting is booked.

 Meeting 3, home visit (research support team):

 -  Collection of device and other equipment

 -  Evaluation on any side effects/adverse events/CRF 4.
Inclusion Criteria:

 -  Meets the International Classification of Headache Disorders (2nd edition) criteria
 for episodic migraine, with or without aura.

 -  Migraine diagnosis >1 year

 -  Migraine attacks 2-8 times/month

 -  Living in Malmö-Lund area

 -  Reliable contraception (fertile women)

 Exclusion Criteria:

 -  Any change of migraine prophylaxis within three months prior to study begin

 -  Failure of participant to adhere to protocol requirements

 -  Smoker or smoker in participants household

 -  Prior nose surgery or intranasal obstruction

 -  Pregnancy, breast feeding or planned pregnancy during trial period

 -  Oxygen dependency

 -  Medical history of skull base fracture or severe facial trauma

 -  No migraine attacks during prolonged screening phase (60 days)