Treatment of Episodic Migraine With AURICular Neuromodulation: a Prospective Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- Number of migraine days in the last 4 weeks of treatment, compared with the initial assessment period (4-week pre-treatment observation).
研究概览
简要总结
Migraine is a ubiquitous pathology affecting approximately 1 billion individuals and being the leading cause of morbidity worldwide before the age of 50. Migraine treatment consists of two main approaches: acute treatment to relieve headache symptoms and preventive treatment to reduce the frequency of migraine attacks by at least 50%. Preventive treatment involves medications such as beta-blockers, antiepileptics, calcium channel blockers, and a new therapeutic class called calcitonin gene-related peptide (CGRP) inhibitors. While traditional treatments have modest efficacy and limited tolerability, CGRP inhibitors have shown better tolerability and superior efficacy. However, their prescription in France is restricted to neurologists and specialized pain evaluation and treatment units. Additionally, the long-term effects of CGRP inhibition on blood pressure control and vascular homeostasis are not fully understood.
In addition to pharmacological preventive treatment, non-pharmacological approaches have emerged, such as auricular neurostimulation. This can be achieved through electrical stimulation of the cymba conchae, considered a non-invasive alternative to invasive vagal stimulation, and has shown benefits in reducing the number of migraine days compared to a placebo. Another approach involves stimulation of specific areas of the entire auricle using techniques borrowed from auriculotherapy (auricular acupuncture).
The objective of the study is to demonstrate that auricular neuromodulation, performed with a laser device, targeted and personalized on selected areas of the auricle, has a beneficial effect on the number of moderate to severe migraine days per month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years ≥ Aged ≤ 60 years
- •Moderate to severe Migraine for at least one year
- •Migraines appeared before the age of 50 and diagnosed according to IHS (international headache society) criteria.
- •Therapeutic failure of at least 2 migraine preventive medications
- •Frequency of migraine days ≥ 4 per month and < 15 per month
排除标准
- •Pathology of the auricle (e.g. epithelioma)
- •Patient treated with botulinum toxin for migraine ≤ 2 months
- •Patient treated with anti-cgrp for migraine, with last injection less than 3 months ago
- •Patient treated with non-invasive auricular stimulation ( TENS)
结局指标
主要结局
Number of migraine days in the last 4 weeks of treatment, compared with the initial assessment period (4-week pre-treatment observation).
时间窗: 4 months
次要结局
- Days without headache or migraine(6 months)
- Migraine attacks duration(6 months)
- Rate of responders, i.e., patients with a 50% reduction in the number of migraine days after treatment compared with the initial assessment(6 months)
- Quality of life of patients measured by Study Short Form 36 (SF-36) questionnaire(6 months)
- Functional disability due to headache or migraine as measured by MIgraine Disability Assessment (MIDAS) and Headache Impact Test (HIT-6) questionnaires(6 months)
- Use of rescue medication(6 months)
- Days without headache or migraine(6 months)
- Migraine attacks duration(6 months)
- Rate of responders, i.e., patients with a 50% reduction in the number of migraine days after treatment compared with the initial assessment(6 months)
- Use of rescue medication(6 months)