IntraNasal Evaporative Cooling for the Symptomatic Relief of Migraine and Cluster Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- • Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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
排除标准
- •< 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%
结局指标
主要结局
• Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers
时间窗: 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.
次要结局
- Adverse events noted throughout treatment phase and during follow up(1 year)
- Tolerance to Rhinochill cooling during maximum 20 minutes treatment(20 minutes)