Using Day-to-day Behavior on Smartphones to Improve Epilepsy Management
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Changes in tapping speed surrounding reported epileptic seizures
研究概览
简要总结
In this prospective cohort study smartphone behavior surrounding epileptic seizures will be quantified, using a smartphone app, in order to optimize epilepsy evaluation and treatment
详细描述
Rationale:
The unpredictability of seizures and the unclear behavioral outcomes are major concerns for people with epilepsy and may surface as increased anxiety about independence. This unpredictability is also a true obstacle in capturing and studying seizure-related neurobehavioral alterations themselves. Also, seizures often impact consciousness and thus may go unnoticed. As a result, subjective seizure diaries are unreliable. Continuous smartphone-based monitoring of behavioral output is a fast-emerging topic and proven fruitful in monitoring other neurological disease states. In the field of epilepsy, these tools are yet to be introduced.
Objective:
The investigators hypothesize that quantifying smartphone behavior will help obtain a detailed and objective behavioral map of seizures that can complement existing subjective seizure diaries and thereby improve the way epilepsy treatments are evaluated in daily practice.
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •clinical diagnosis of refractory focal epilepsy meeting ILAE criteria16, 17
- •supported by at least one of the following; (1) interictal EEG with epileptiform discharges, (2) epileptogenic lesion on MRI corresponding to the presumed seizure onset zone, or (3) seizure recorded during a video-EEG
- •have a seizure frequency of ≥ 1 per month
- •only one seizure type, or in case of multiple seizure types only seizures that correspond to one probable onset zone (e.g. focal and focal to bilateral tonic-clonic seizures)
- •have daytime seizures (exclusively or both daytime and night-time seizures)
- •mentally competent and with no learning disabilities
- •able to keep a seizure diary including time and date (as judged by the treating physician)
- •have an Android-operating smartphone
- •use their phone with at least 5 distinct smartphone apps at a minimum of 5 days a week
排除标准
- •not fulfilling the above mentioned inclusion criteria
结局指标
主要结局
Changes in tapping speed surrounding reported epileptic seizures
时间窗: 3 months
The tapping speed will be measured using the TapCounter app by QuantActions
Changes in time spent using the smartphone surrounding reported epileptic seizures
时间窗: 3 months
The phone usage in hours will be measured using the TapCounter app by QuantActions
Changes in number of apps used surrounding reported epileptic seizures
时间窗: 3 months
The number of apps used will be measured using the TapCounter app by QuantActions
Changes in speed of unlocking the smartphone surrounding reported epileptic seizures
时间窗: 3 months
The unlocking speed will be measured using the TapCounter app by QuantActions
次要结局
- Recovery after seizure(3 months)
- Comparison of seizures in diaries and seizures in app use(3 months)
- Subgroup analysis(3 months)