Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study

Study Overview
=================
Brief 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.

Official Title
-----------------
Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Device: Nasal cavity cooling device.


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single group assignment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhinochill<br>Treatment with nasal cavity cooling 10 minutes during three consecutive migraine attacks. | Device: Nasal cavity cooling device.<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of headache | Scoring of headache on a 4-graded scale (none-mild-moderate-severe). | 10 minutes after baseline (immediately after treatment) compared to baseline | 
| Reduction of nausea | Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding nausea | 10 minutes after baseline (immediately after treatment) compared to baseline | 
| Reduction of photophobia | Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophobia | 10 minutes after baseline (immediately after treatment) compared to baseline | 
| Reduction of phonophobia | Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophonia | 10 minutes after baseline (immediately after treatment) compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache response | The patient scores the headache symptoms on a 4-graded scale (none-mild-moderate-severe). Any improvement of pain is recorded. | Comparing baseline/before treatment and 1. immediately following treatment (10 minutes),2. 1 hour, 3. 2 hours and 4. 24 hours following treatment. | 
| Relapse incidence | Frequency of headache returns | Between 2-48 hours after intervention | 
| Sustained pain freedom, number of patients that sustain pain freedom 2-48 hours after intervention. | pain free with no use of rescue medication or relapse | 2-48 hours after intervention | 
| Impact on nausea | Scoring of symptoms none-mild-moderate-severe regarding nausea | At baseline and 1, 2, 24 hours after treatment | 
| Impact on photophobia | Scoring of symptoms none-mild-moderate-severe regarding photophobia | At baseline and 1, 2, 24 hours after treatment | 
| Impact on phonophobia | Scoring of symptoms none-mild-moderate-severe regarding , photophobia and phonophobia | At baseline and 1, 2, 24 hours after treatment | 
| Comparison of headache response between RhinoChill compared to standard treatment during screening period | Comparison of average treatment effect on headache respons between standard treatment and intervention. Scoring of headache on a 10-graded scale, where higher values represents more pain | Screening phase compared to intervention phase | 
| Average headache pain relief | Scoring of pain on a 4-graded scale, (none-mild-moderate-severe) compared to baseline. | At baseline and 10 minutes, 1, 2 and 24 hours after treatment. | 
| Tolerance to rhinochill cooling - pain | Visual/analogue pain on a 10-graded scale, where higher values represents more pain. | 10 minutes-1 hour | 
| Tolerance to rhinochill cooling - discomfort | Visual/analogue discomfort score, on a 10-graded scale, where higher values represents more discomfort. | 10 minutes-1 hour | 
| Adverse events | Any adverse events noted during the treatment, following treatment or during follow up | through study completion, an approximated average of 3 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine