Intranasal Cooling for Cluster Headache and Migraine

Not Applicable

Completed

• Conditions: Cluster Headache; Migraine
• Interventions: Device: RhinoChill intranasal cooling

• Registration Number: NCT01898455
• Lead Sponsor: Cumbria Partnership NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-12
• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-03
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intranasal Cooling	RhinoChill intranasal cooling	RhinoChill Intranasal cooling, administered for 20 minutes. 10 treatment sessions per participant.

Primary Outcome Measures

Name	Time	Method
• Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers	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

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

Trial Locations

Locations (1)

Neurosciences department, Penrith Hospital, Cumbria Partnership NHS Foundation Trust; 🇬🇧 Penrith, Cumbria, United Kingdom