Smartphone Behavior and Epilepsy Management
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| subjects with refractory focal epilepsy with a seizure frequency 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
The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions
|
Outcome Measures
Primary Outcome Measures
- Changes in tapping speed surrounding reported epileptic seizures [3 months]
The tapping speed will be measured using the TapCounter app by QuantActions
- Changes in number of apps used surrounding reported epileptic seizures [3 months]
The number of apps used will be measured using the TapCounter app by QuantActions
- Changes in time spent using the smartphone surrounding reported epileptic seizures [3 months]
The phone usage in hours will be measured using the TapCounter app by QuantActions
- Changes in speed of unlocking the smartphone surrounding reported epileptic seizures [3 months]
The unlocking speed will be measured using the TapCounter app by QuantActions
Secondary Outcome Measures
- Recovery after seizure [3 months]
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
- Comparison of seizures in diaries and seizures in app use [3 months]
See if reported seizure incidence matches with seizure incidence deducted from smartphone measurements
- Subgroup analysis [3 months]
Analyze differences in behavioural patterns between individuals with different types of epilepsy (e.g. different seizure types or onset zones)
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥ 18 years of age
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clinical diagnosis of refractory focal epilepsy meeting ILAE criteria16, 17
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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
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have a seizure frequency of ≥ 1 per month
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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)
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have daytime seizures (exclusively or both daytime and night-time seizures)
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mentally competent and with no learning disabilities
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able to keep a seizure diary including time and date (as judged by the treating physician)
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have an Android-operating smartphone
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kempenhaeghe | Heeze | Noord-Brabant | Netherlands | 5591 VE |
| 2 | Stichting Epilepsie Instellingen Nederland | Heemstede | Noord-Holland | Netherlands | 2103 SW |
| 3 | Maasstad ziekenhuis | Rotterdam | South Holland | Netherlands | 3079 DZ |
Sponsors and Collaborators
- Stichting Epilepsie Instellingen Nederland
- Leiden University
Investigators
- Principal Investigator: Roland D Thijs, MD PhD, Stichting Epilepsie Instellingen Nederland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SB&EM