Evaluation of the Impact of Wearing a Millimetre Wave Bracelet for 3 Months on the Frequency in Number of Days of Migraines in Patients With Episodic Migraines Without Aura
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 12
- 主要终点
- To evaluate the effects of millimeter waves applied to the wrist (MMW) on the number of days with migraine(s) at 3 months reported by the patient with episodic migraine(s) without aura.
研究概览
简要总结
Migraine is a neurovascular disease whose prevalence is estimated at almost 20% of the adult population. Currently, there is no treatment for migraine.
Millimeter stimulation of the wrist subcutaneous receptors allows the release of endorphin in the brain.
MISTIC is a prospective, controlled, multicenter, double-blind, randomized study in which the research team are investigating whether millimeter stimulation of subcutaneous wrist receptors reduces the frequency of migraine crisis.
详细描述
MISTIC is a multicenter, controlled, randomized, double-blind study. Eligible patients will have to report their migraine crisis in a diary during a one month pre-selection phase. Then, patients will be randomized into one of two treatment groups :
- active millimeter wave emission bracelet
- or placebo bracelet
Patients will have to use the medical device twice a day for 3 months. The investigators will follow them for an additional 3 months to assess the persistence of the effect.
Throughout the follow-up, patients will report their migraines crisis in a journal.
The primary outcome will be the impact of wearing a millimeter wave bracelet for 3 months, on the number of days with migraine headaches.
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
- Triple (Participant, Care Provider, 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
- •Patient with episodic migraine without aura (according to ICDH3 classification criteria)
- •Patient with at leat 4 migraine days per month and no more than 8 migraine days per months
- •Background treatment (or not) stable for at least 1 month
- •Drug management of migraine stable for at least one month
- •Non-drug management of stable migraine at least 1 month prior to the study
- •Patient affiliated to social security or beneficiary of such a scheme
排除标准
- •Patients with chronic migraine (defined according to IHS criteria)
- •Patients already included in an interventional clinical research protocol
- •Patients with chronic headache due to drug abuse (according to IHS criteria)
- •Patients with only migraine crisis with aura
- •Wrist size < 14.5 and > 21 cm
- •Situations of dermatological pathologies on pre-existing wrists (oozing dermatosis, hyper sweating, eg.) or unhealed lesions on both wrists.
- •Presence of metallic object (bracelet, watch, piercing...) on both wrists.
- •Presence of a tattoo on both wrists
- •Allergic reactions on contact with silicone or metal
- •Persons referred to in Articles L 1121-5 to L 1121-8 of the CSP (corresponds to all protected persons) pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure
- •Women of childbearing age with a short-term pregnancy project
结局指标
主要结局
To evaluate the effects of millimeter waves applied to the wrist (MMW) on the number of days with migraine(s) at 3 months reported by the patient with episodic migraine(s) without aura.
时间窗: 3 months.
Sequential hierarchical analysis on two criteria : * the difference in the number of days with migraine in the month prior to M3, taking into account the number of days with migraine in the month prior to inclusion, using an ANCOVA (comparison of average between the 2 groups adjusted to the initial value according to the recommendations of Vickers and Altman). * the difference in the proportion of success at M3 (reduction in the number of days with migraine by more than 50% between inclusion and M3), evaluated by the Chi2 test.
次要结局
- To compare the evolution of migraine in terms of monthly monitoring.(3 months.)
- To evaluate the effects of wearing a millimeter wave wristband on associated anxiety and depressive disorders.(3 months.)
- To assess the consumption of complementary alternative migraine care between the 2 groups.(3 months.)
- To evaluate the stability of the effect of wearing the MMW wristband over the long term in the intervention group.(6 months.)
- Observance of the use of MMW wristband.(3 months.)
- To evaluate the effects of wearing a millimeter wave wristband on the duration of migraine crisis.(3 months.)
- To evaluate the effects of wearing the MMW wristband on generic quality of life.(3 months.)
- To evaluate the consumption in consultations (any type of care use) for migraine between the 2 groups.(3 months.)
- Adverse events.(6 months.)
- To assess patient satisfaction with participation in the study.(6 months.)
- Subgroup analysis of the number of migraine day for the principal outcome in relation to patients with or without prior prophylactic treatment.(6 months.)
- To evaluate the effects of wearing a millimeter wave wristband on the severity of migraine crisis.(3 months.)
- Evaluation of the consumption of migraine crisis treatments between the 2 groups.(3 months.)
- To evaluate the effects of wearing the MMW wristband on the specific (i.e. migraine-related) quality of life of migraine patients (functional disability).(3 months.)
- To evaluate the effects of wearing a millimeter wave wristband on the quality of sleep.(3 months.)