Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nasal cavity cooling device.
Intervention type(s): Device
Intervention description(s): The RhinoChill® system cools by intranasal evaporation of a liquid coolant sprayed onto the surface of the nasal cavity. The RhinoChill® system is intended for use for the relief of pain and symptoms associated with acute migraine attack.
Intervention model: Single Group Assignment
Intervention model description: Single group assignment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine