Intranasal Cooling for Cluster Headache and Migraine

Cumbria Partnership NHS Foundation Trust15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Migraine Cluster Headache

Interventions

RhinoChill intranasal coolingDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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%

Outcomes

Primary Outcomes

• 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.

Time frame: 20 minutes

Secondary Outcomes

Tolerance to Rhinochill cooling during maximum 20 minutes treatment

Visual/analogue pain score and visual/analogue discomfort score

Time frame: 20 minutes

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.

Time frame: 1 year