Proof-of-concept Study on the Efficacy of Light Therapy in the Prophylactic Treatment of Chronic Cluster Headache
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- The median weekly number of cluster headache attacks
研究概览
简要总结
Cluster headache is a primary headache. The chronic form of the disease is often difficult to treat. It is now considered a chronobiological disease. This chronobiological character is based on clinical, biological and radiological arguments.
This study focuses on the use of light therapy in cluster headache. Light therapy has already been used in the treatment of other chronobiological diseases, such as seasonal depression, but also recently in the therapy of other primary headaches (such as migraine). Its aim is to re-adjust chronobiological rhythms, and it therefore seems worth testing in the chronic form of cluster headache.
Light therapy is delivered to the patient using a consumer electronics device.The main objective is to evaluate the prophylactic efficacy of light therapy in patients with chronic cluster headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Male or female, of 18 years years old or more;
- •Diagnosis of chronic cluster headache according to ICHD-3 criteria;
- •Number of seizures during baseline equal to at least 24;
- •Stability of prophylactic treatment for at least 1 month and commitment not to change it for the duration of the study;
- •Patient affiliated to the French social security system.
- •Patient who understands and speaks French correctly;
- •Patient who has given free and informed written consent.
排除标准
- •Contraindication to the use of light therapy: use of a photosensitizing treatment;
- •Ophthalmological history: cataract, macular degeneration, glaucoma, retinitis pigmentosa;
- •Patients who work at night;
- •Other neurological, psychiatric or developmental pathologies considered incompatible with the study;
- •Background treatment of cluster headache with melatonin;
- •Persons protected by articles L1121-5, L1121-6 and L1121-8 of the French Public Health Code (pregnant or breast-feeding women, persons deprived of their liberty by judicial decision, socially vulnerable persons, adults incapable or unable to express their consent).
结局指标
主要结局
The median weekly number of cluster headache attacks
时间窗: At day 28
The difference in the median weekly number of cluster headache attacks between the month prior to randomization and the month of the double-blind period, between the two arms.
次要结局
- Incidence and nature of adverse reactions(Daily)
- Intensity of cluster headache(Daily)
- Use of acute treatments(Daily)
- Patient's Global Impression of Change (PGIC) score(At day 28)