Intranasal Cooling for Cluster Headache and Migraine (COOLHEAD)

Cumbria Partnership NHS Foundation Trust

Status

Completed

Conditions

Migraine

Cluster Headache

Treatments

Device: RhinoChill intranasal cooling

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01898455

CPFT001

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%