Open-trial on the Prevention of Chronic Migraines With the CEFALY Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Change From Baseline in Frequency of Headache Days
研究概览
简要总结
The main objective of this study was to assess the safety and efficacy of the Cefaly® e-TNS device as a prophylactic treatment of chronic migraine in adult patients.
详细描述
The purpose of this pilot study was to assess the safety and efficacy of the Cefaly® e-TNS device in the prophylactic treatment of chronic migraine in adult patients prior to implement a control trial where the size and final protocol will be specified thanks to the outcomes of this pilot trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a history of chronic migraine meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine (1), with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, migraine with brainstem aura, ophthalmoplegic migraine-recurrent painful ophthalmoplegic neuropathy, migrainous infarction) will be enrolled. They are required during baseline to have ≥15 headache days with each day consisting of ≥4 hours of continuous headache and with ≥50% of days being migraine or probable migraine days; and ≥4 distinct headache episodes, each lasting ≥4 hours.
- •Both patients with or without acute medication overuse (medication overuse headache - MOH) will be recruited
排除标准
- •Women: Pregnant, lactating or <6 months post partum
- •For patients already on treatment with medications in the following classes: antihypertensives, antidepressants, antiepileptics, no dose change of those medications is allowed for at least 3 months before start of baseline and during the entire study period.
- •For patients treated with Botox, no injection within 4 months before start of baseline or during the study.
- •Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
- •A Beck Depression Inventory score of >24 at baseline
- •Psychiatric disorders that could have interfered with study participation
- •Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)
研究组 & 干预措施
Active
Daily trigeminal nerve stimulation session of 20 minutes with CEFALY
干预措施: CEFALY (Device)
结局指标
主要结局
Change From Baseline in Frequency of Headache Days
时间窗: End of baseline period and end of 12 weeks treatment period
Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.
Change From Baseline in Acute Medication Intake
时间窗: End of baseline period and end of 12 weeks treatment period
Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment.
次要结局
- Change in Frequency of Migraine Days(End of baseline period and end of 12 weeks treatment period)
- Change in Frequency of Moderate/Severe Headache Days(End of baseline period and end of 12 weeks treatment period)
- 50% Responder Rate for Migraine Days(End of the 12 weeks treatment period)
- Change in Monthly Cumulative Headache Hours(End of baseline period and end of 12 weeks treatment period)
- Change in Frequency of Headache Episodes(End of baseline period and end of 12 weeks treatment period)
- Change in the Average Headache Intensity(End of baseline period and end of 12 weeks treatment period)