Intranasal Cooling for Cluster Headache and Migraine

Migraine Clinical Trial

— COOLHEAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898455
• Other study ID #: CPFT001
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: December 3, 2014
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: Cumbria Partnership NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics CommitteeUnited Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cluster Headache
• Headache
• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust	Penrith	Cumbria

Sponsors (2)

Lead Sponsor	Collaborator
Cumbria Partnership NHS Foundation Trust	BeneChill, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Secondary	Tolerance to Rhinochill cooling during maximum 20 minutes treatment	Visual/analogue pain score and visual/analogue discomfort score	20 minutes	No
Secondary	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	Yes