Efficacy of a Novel App-based Migraine Treatment Platform - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- Headache frequency
研究概览
简要总结
This study evaluates biofeedback delivered through a smartphone as a treatment for migraine in adolescents. Three out of four participants will receive treatment as smartphone delivered biofeedback training, and one out of four participants will receive treatment as a sham-biofeedback app.
详细描述
Biofeedback is a behavioral treatment without known side effects. In biofeedback patients learn control over bodily reactions through feedback visualised on a screen. Typical bodily reactions that are displayed is heart rate and muscle tension. Biofeedback has for decades been considered as effective preventive treatment of migraine among children and adolescents. In spite of that, it is not available to most patients in need. This is most likely because it requires specialised stationary equipment and a trained therapist.
In this project, the researchers have developed a new smartphone biofeedback app connected to wearable, wireless sensors measuring muscle tension, finger temperature and heart rate. The app and sensors will be used to deliver biofeedback treatment to adolescents suffering for migraine. The goal of the study is to investigate the effect of the biofeedback treatment and the sham-biofeedback treatment on 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)
盲法说明
The randomization number will be drawn sequentially from a list of 40 numbers where one random in every four numbers results in downloading a sham-version of the app. Both versions of the app look alike and no pattern in the 5-digit number or the randomization list can reveal which version of the app is given. This will ensure blinding of both participants and study personnel. Breaking of the randomization will be made after follow-up of the last participant. The software developers will at this point reveal what 5-digit numbers corresponded to the biofeedback or sham version of the app.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of migraine with or without aura according to ICHD-3
- •two to eight migraine attacks per month
- •written informed consent signed by guardians, or by adolescent if age between 16-18 years.
排除标准
- •participant not speaking Norwegian
- •reduced sensibility, hearing or vision to a degree that impairs proper use of the app
- •serious psychiatric or neurologic disease and
- •currently using migraine prophylaxis.
结局指标
主要结局
Headache frequency
时间窗: Baseline and last 28 days of treatment
Mean change in headache frequency from baseline to end of treatment. Evaluated as number of headache days.
次要结局
- Maximal pain intensity(Baseline and last 28 days of treatment)
- Responder rate(Baseline and last 28 days of treatment)
- Abortive drug consumption(Baseline and last 28 days of treatment)