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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
Sponsor:
Collaborator:
BeneChill, Inc
Information provided by (Responsible Party):
Cumbria Partnership NHS Foundation Trust

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Cluster Headache Device: RhinoChill intranasal cooling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
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.
Other Names:
  • RhinoChill
  • Intranasal cooling
  • transnasal cooling


Outcome Measures
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Primary Outcome Measures :
  1. • 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.


Secondary Outcome Measures :
  1. Tolerance to Rhinochill cooling during maximum 20 minutes treatment [ Time Frame: 20 minutes ]
    Visual/analogue pain score and visual/analogue discomfort score

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust
Penrith, Cumbria, United Kingdom, CA11 8HX
Sponsors and Collaborators
Cumbria Partnership NHS Foundation Trust
BeneChill, Inc
Investigators
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Principal Investigator: Jitka Vanderpol, MD Cumbria Partnership NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cumbria Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01898455    
Other Study ID Numbers: CPFT001
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Keywords provided by Cumbria Partnership NHS Foundation Trust:
Migraine
Cluster headache
headache
Additional relevant MeSH terms:
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Migraine Disorders
Cluster Headache
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias