NCT01898455

Intranasal Cooling for Cluster Headache and Migraine

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Cumbria Partnership NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine
• Cluster Headache

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-07-12
• Last updated: 2014-12-04

Locations

1 site across 1 country: United Kingdom