Intranasal Cooling for Cluster Headache and Migraine (COOLHEAD)
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|ClinicalTrials.gov Identifier: NCT01898455|
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : December 4, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Migraine Cluster Headache||Device: RhinoChill intranasal cooling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IntraNasal Evaporative Cooling for the Symptomatic Relief of Migraine and Cluster Headache|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Intranasal Cooling
RhinoChill Intranasal cooling, administered for 20 minutes. 10 treatment sessions per participant.
Device: RhinoChill intranasal cooling
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.
- • Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers [ Time Frame: 20 minutes ]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.
- Tolerance to Rhinochill cooling during maximum 20 minutes treatment [ Time Frame: 20 minutes ]Visual/analogue pain score and visual/analogue discomfort score
- Adverse events noted throughout treatment phase and during follow up [ Time Frame: 1 year ]• Any adverse events noted during the treatment or following treatment and during routine follow up will be recorded and analysed.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- >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
- < 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%
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898455
|Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust|
|Penrith, Cumbria, United Kingdom, CA11 8HX|
|Principal Investigator:||Jitka Vanderpol, MD||Cumbria Partnership NHS Foundation Trust|
|Responsible Party:||Cumbria Partnership NHS Foundation Trust|
|Other Study ID Numbers:||
|First Posted:||July 12, 2013 Key Record Dates|
|Last Update Posted:||December 4, 2014|
|Last Verified:||December 2014|
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases
Trigeminal Autonomic Cephalalgias