Using Day-to-day Behavior on Smartphones to Improve Epilepsy Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Stichting Epilepsie Instellingen Nederland
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Changes in tapping speed surrounding reported epileptic seizures
- Last Updated
- 3 years ago
Overview
Brief Summary
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
Detailed Description
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: A multicentre observational prospective cohort study with at least 3 months follow-up. Study population: 100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month. Main study parameters/endpoints: Change in touchscreen interactions (tapping speed, texting speed, apps used, location, sleep-wake cycles) surrounding reported epileptic seizures.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 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
Exclusion Criteria
- •not fulfilling the above mentioned inclusion criteria
Outcomes
Primary Outcomes
Changes in tapping speed surrounding reported epileptic seizures
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 3 months
The unlocking speed will be measured using the TapCounter app by QuantActions
Secondary Outcomes
- Recovery after seizure(3 months)
- Comparison of seizures in diaries and seizures in app use(3 months)
- Subgroup analysis(3 months)