Intranasal Cooling for Cluster Headache and Migraine

Study Overview
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Brief Summary
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This study will be looking at the clinical efficacy of using a intranasal evaporative cooling device in providing relief of the symptoms of migraine and cluster headache. It will involve using a nasal catheter to spray a liquid coolant into the nasal cavity where it evaporates and removes heat from the tissue, thereby cooling the tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict and it is thought that this may provide symptomatic relief in both these forms of headache. 10 migraine patients and 5 cluster headache patients will be enrolled in the study and will receive 10 treatments each, for a maximum of 20 minutes at a time. They will be monitored during the treatment and for two hours afterwards to assess headache severity and side effects. There will be a further follow up 2 months after the last treatment to assess for longer term side effects from the treatment.

Official Title
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IntraNasal Evaporative Cooling for the Symptomatic Relief of Migraine and Cluster Headache

Conditions
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Migraine, Cluster Headache

Intervention / Treatment
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* Device: RhinoChill intranasal cooling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 Years old. Meets criteria for NICE guidelines diagnosis of cluster headache or chronic migraine Has not responded satisfactorily to migraine prophylaxis or standard analgesia Capable of giving informed consent Exclusion Criteria: < 18 years of age Subject has history of other severe co-morbid illness which would prevent full participation in the study Inability to insert the nasal cannulae Known temperature sensitive disorder such as reynauds, cryoglobulinaemia Known oxygen dependency to maintain SaO2 >95%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Cooling<br>RhinoChill Intranasal cooling, administered for 20 minutes. 10 treatment sessions per participant. | Device: RhinoChill intranasal cooling<br>* The RhinoChill device will be used to locally cool the posterior nasopharynx, surrounding tissues and vasculature using a variable cooling flow rate based on patient comfort and tolerance, for a maximum of 20 minutes. Local anaesthetic spray will be administered to patients if the nasal catheters or cooling is poorly tolerated.<br>* Other names: transnasal cooling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers | When a participant presents with headache, baseline assessments will be performed for pain, nausea and other recognised symptoms of migraine/cluster headache. The Rhinochill device will be used to provide transnasal cooling for a period of 20 minutes then reassessment of pain and other symptoms will be undertaken. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance to Rhinochill cooling during maximum 20 minutes treatment | Visual/analogue pain score and visual/analogue discomfort score | 20 minutes | 
| Adverse events noted throughout treatment phase and during follow up | • Any adverse events noted during the treatment or following treatment and during routine follow up will be recorded and analysed. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Cluster headache, headache