A Research Study to Examine Cutaneous Allodynia and Cluster Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Prevalence of Allodynia in Subjects With Cluster Headache
研究概览
简要总结
This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraines; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if the investigators are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals. Sixty patients will be screened for this study. Thomas Jefferson University is the only center enrolling patients in this research study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18-75, inclusive
- •Diagnosis of cluster headache, episodic or chronic.
- •Patients with episodic CH can be either in active cluster period or not.
- •Ability to read and understand an informed consent form, where the study protocol is described.
排除标准
- •Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
- •Patients who are cognitively impaired, as determined by investigator
- •Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
- •Patients who had taken an acute pain medication within 24 hours prior to allodynia testing.
- •Patients with skin diseases that may cause abnormal skin sensation.
- •Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing
- •Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing
结局指标
主要结局
Prevalence of Allodynia in Subjects With Cluster Headache
时间窗: Allodynia was assessed at the screening visit
Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.
次要结局
未报告次要终点
研究者
Stephen D. Silberstein
Professor of Neurology
Thomas Jefferson University