Smartphone Behavior and Epilepsy Management

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using Day-to-day Behavior on Smartphones to Improve Epilepsy Management

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Change in touchscreen interactions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| subjects with refractory focal epilepsy with a seizure frequency<br>The investigators will include 100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month, and ask them to keep a seizure diary and use the TapCounter app for three months. | Behavioral: Change in touchscreen interactions<br>* The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tapping speed surrounding reported epileptic seizures | The tapping speed will be measured using the TapCounter app by QuantActions | 3 months | 
| Changes in number of apps used surrounding reported epileptic seizures | The number of apps used will be measured using the TapCounter app by QuantActions | 3 months | 
| Changes in time spent using the smartphone surrounding reported epileptic seizures | The phone usage in hours will be measured using the TapCounter app by QuantActions | 3 months | 
| Changes in speed of unlocking the smartphone surrounding reported epileptic seizures | The unlocking speed will be measured using the TapCounter app by QuantActions | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery after seizure | See how long does it take to behaviorally recover after a seizure, this will be assessed using the TapCounter app and seeing when phone usage before and after the reported seizure are similar again | 3 months | 
| Comparison of seizures in diaries and seizures in app use | See if reported seizure incidence matches with seizure incidence deducted from smartphone measurements | 3 months | 
| Subgroup analysis | Analyze differences in behavioural patterns between individuals with different types of epilepsy (e.g. different seizure types or onset zones) | 3 months |