Intranasal Cooling for Symptomatic Relief of Migraine
Intranasal Cooling for Symptomatic Relief of Migraine
This study will be a randomised placebo controlled trial examining the effectiveness of using
 an intranasal cooling device (the RhinoChill) in providing relief of pain and symptoms of
 acute migraine. It will involve using two nasal catheters to cool the nasal cavity which
 provides localised cooling of 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. Ninety patients will be
 randomised in a 1:1 fashion, clustered to three different recruitment sites. 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.
This study is a multi centre, double blinded, randomized, prospective, parallel placebo
 controlled trial for demonstrating the effectiveness of the RhinoChill System for the
 symptomatic relief of migraine headache.

 The specific study design consists of:

 -  Participant identification from neurology clinic records and gaining initial consent to
 transfer contact details to the trial team.

 -  Telephone contact or direct clinic contact with potential participants to describe the
 COOLHEAD 2 trial and to seek expressions of interest.

 -  Initial meetings with potential participants and discussion of trial, provision of
 patient information leaflets. Informed Consent taking.

 -  Initial 30 day prospective data collection period (minimum of 2 migraine attacks, longer
 period if needed)

 -  Randomisation to either placebo or active RhinoChill

 -  Device Delivery and training session for the use of the RhinoChill device, self
 administration, and record keeping.

 -  Treatment period for the treatment of 2 separate migraines with the RhinoChill.

 During an initial screening visit or phonecall, the trial will be discussed with the
 potential participant and the inclusion/exclusion checklist will be completed.

 If the patient meets all inclusion criteria and none of the exclusion criteria, they will be
 asked for permission to pass on contact details to a member of the trial team for further
 contact.

 Arrangements will then be made for a meeting with the patient either at the clinic or in
 their own home to further discuss the trial and to consider enrolling into the study. At this
 time, they will be provided with a patient information sheet and will be shown the RhinoChill
 device. The patient will be given the opportunity to fully consider all aspects of
 participation in this trial and to discuss it with family members if they so wish before
 being being consented into the trial by a member of the study team.

 At the time of consent, the researcher will also collect data for the baseline CRF and
 provide initial instruction on completion of the first stage data collection forms (further
 described below)

 At the baseline visit, the patient will first be given the opportunity to ask any questions
 they may have about the research. A member of the research team will take informed consent
 and gain signatures on the consent form. Baseline data will then be collected, including
 history of migraine headache, frequency, severity of symptoms, medication and therapies
 currently ongoing or taken in the past. Base line vital signs will also be recorded at this
 time. Once completed, a short training session on completion of the prospective data
 collection forms for phase 1 of the trial will given and use of the supplied blood pressure
 machine and pulse oxymeter machine. Once the baseline visit has been completed the patient
 will begin a 30 day period of self data collection based on their migraine experience during
 that time frame and using data capture forms provided by the research nurse (a minimum of 2
 migraine attacks are required, therefore if 2 have not occurred during the 30 days, further
 time will be given to allow the second migraine to occur).

 If a patient has not had a single migraine in the first 30 days, then they will not be able
 to continue to the treatment phase as they have not met the inclusion criteria of at least 1
 migraine per month. Following the conclusion to this initial period, the treatment phase will
 then begin.

 After the end of the prospective data collection period, the patient will be randomised to
 either active treatment or placebo treatment. Randomisation will be provided by sealed
 envelopes held by E&E CRO services (Vienna) who are also acting as independent monitors of
 the trial. Randomisation was performed via the online system www.sealedenvelope.com.

 Training will be undertaken to ensure that the patient is fully competent and safe in the use
 of the RhinoChill intranasal cooling device.

 The patient will be instructed on:

 -  Preparation of the device

 -  Insertion of the nasal catheter

 -  Selecting correct flow rate

 -  Positioning during treatment

 -  Cleaning and storage of the nasal catheters

 -  Trial documentation

 -  24 hour contact numbers for additional supplies, troubleshooting and practical support.

 The patient will also be left with a reference booklet for issues around the trial and the
 practical use of the RhinoChill device.

 At the onset of migraine headache (or as soon as possible thereafter), the patient will start
 to complete the 'Treatment' CRF.

 Each step of the treatment procedure is to be completed in order and as described to the
 patient. Patients are instructed that there is no scope for any alteration in the treatment
 order or requirements of the trial unless a safety issue becomes evident. If a patient does
 deviate from the standard procedures as outlined below, they are required to contact the 24
 hour COOLHEAD 2 mobile phone to report the incident so that it can be reviewed and logged as
 a protocol deviation and reviewed by the site/principal investigator at the earliest
 opportunity. The RhinoChill device is then prepared for use and treatment can be
 administered.

 The RhinoChill Migraine Intranasal catheters are then inserted and the 10 minute treatment is
 commenced on Low Flow. following these steps for each individual treatment:

 It is recognised that participants in this study will already be taking medication for their
 migraine headache. Normal prophylaxis will be allowed as part of the trial and will be
 recorded in the initial screening interview. No change in prophylaxis is allowed within three
 months of the start of the trial or while the patient is participating in the trial.

 However, acute treatments such as triptans are allowed to be taken but must be withheld until
 at least two hours following completion of treatment with the RhinoChill to allow assessment
 of the intervention. Any rescue medication taken after this point will be recorded in the
 associated trial documentation. A full medication history along with other therapies
 (including alternative therapies) will also be recorded.

 No new treatment or therapy will start while the participant is enrolled in this trial.
Inclusion Criteria:

 -  18 Years or over and ≤70 years of age.

 -  Migraine diagnosis of at least 1 year.

 -  Migraine attacks between 1 and 15 per month.

 -  Onset of first migraine < 50 years of age.

 -  Migraine prophylaxis medication unchanged for 3 months prior to enrollment

 -  Meets International Classification for Headache Disorders (2nd Edition) criteria for
 diagnosis of Episodic Migraine with or without aura

 -  Able to attend and understand a short training session on the practical use of the
 RhinoChill device and agrees to only use the device as instructed and as laid out in
 the official instructions for use.

 Exclusion Criteria:

 -  < 18 and >70 years of age

 -  Known oxygen dependency to maintain SaO2 >95%

 -  Diagnosed Hypertensive and currently uncontrolled with Systolic BP > 140mmHg and
 Diastolic BP > 90mmHg on baseline assessment.

 -  Marked nasal septal deviation, recurrent epistaxis or chronic Rhino-Sinusitis

 -  Intranasal obstruction preventing full insertion of nasal catheter

 -  Known acute base of skull fracture or facial trauma

 -  Concurrent sinus/intranasal surgery

 -  Diagnosed with thromobocytopenia.

 -  Previous Stroke or Myocardial Infarction

 -  Unable to fully understand the consent process and provide informed consent due to
 either language barriers or mental capacity

 -  Previously enrolled into the COOLHEAD 1 trial

 -  No recorded migraine following initial 30 day data collection period