A Prospective Feasibility Study of Daily, Home-based Biofeedback Therapy Using Cerebri for Migraine Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of intervention assessed by number of days with logged headache per 28-day period, number of biofeedback sessions per 28-day period, and mean session duration
研究概览
简要总结
The purpose of this study is to investigate feasibility, usability, safety, efficacy, and tolerability of Cerebri biofeedback treatment for adults with episodic migraine.
In the study, the app-based biofeedback treatment Cerebri for migraines in adults will be tested. By using biofeedback, bodily signals that are thought to be associated with migraines, are measured. During the treatment, one sensor is attached on the shoulder to measure activity in the shoulder and neck muscles and one sensor is attached to the index finger to measure temperature and heart rate variability. By getting on-screen feedback on the phone, the user can learn techniques to reduce muscle tension, and increase finger temperature and heart rate variability. Reduced muscle tension, as well as increase in finger temperature and heart rate variability is a sign of relaxation and a deactivation of the nervous system, which can lead to fewer and less serious migraine attacks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •18 years of age or older, at the time of signing the informed consent
- •Episodic migraines with or without aura diagnosed by a neurologist/physician per International Classification of Headache Disorders 3rd edition (ICHD-3).
- •Having kept a headache diary with at least 80% adherence as part of routine clinical care in the last 28-days prior to inclusion.
- •History of at least 4 and up to 14 days of migraines per 28-day period in the 3 months prior to screening, as recalled by the subject and confirmed in the clinical diary.
- •At least three months of experience with smartphone and access to an iOS or Android phone at home.
- •Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Onset of migraine before age 50 years.
排除标准
- •Having a continuous background headache that never disappears completely.
- •More than 14 days of headache (all types) per 28-day period.
- •Subjects diagnosed with trigeminal autonomic cephalalgias and neuralgias.
- •Subjects with secondary headache conditions.
- •Subjects with headaches attributed by the treating neurologist/physician as being medication overuse headache according to the ICHD-
- •Subject with pathologies that inhibit use of the device according to the instructions for use (e.g., blindness, deafness).
- •Use of any concurrent preventive treatment (medications, meditation, physical therapy and psychotherapy as a headache treatment, acupuncture, etc.).
- •Subjects who have previously failed three prophylactic pharmacological treatments.
- •Subjects taking opioids (>3 days per month) or barbiturates at the time of screening.
- •Subject participates in another clinical investigation.
- •Alcohol overuse according to ICD-10-CM Code F10.1 or illicit drug use.
- •Subject who is unlikely to follow Clinical Investigation Plan or where treatment seems futile in the opinion of the Investigator or have demonstrated an inability to sufficiently adhere to headache diary entries (<80%).
结局指标
主要结局
Feasibility of intervention assessed by number of days with logged headache per 28-day period, number of biofeedback sessions per 28-day period, and mean session duration
时间窗: 3 months
Extraction of data from headache diary and completed biofeedback sessions
次要结局
- Usability of intervention assessed by mHealth app usability questionnaire (MAUQ)(3 months)
- Descriptive assessment of users' experience of use of intervention, by semi-structured interviews to evaluate design and ease of use(3 months)
- Change in subject-reported, headache-related disability assessed by Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)(3 months)
- Usability of intervention assessed by modified System Usability Scale (SUS) questionnaire(3 months)
- Initial estimates of efficacy and onset of efficacy assessed by number of migraine days(3 months)
- Descriptive assessment of patients' belief about treatment efficacy assessed by Patient Global Impression of Change Scale (PGIC)(3 months)