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| Name | Class |
|---|---|
| Leiden University | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change in touchscreen interactions | Behavioral | The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur R van Nieuw Amerongen | Contact | +31235588018 | avnieuwamerongen@sein.nl |
| Name | Affiliation | Role |
|---|---|---|
| Roland D Thijs, MD PhD | Stichting Epilepsie Instellingen Nederland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kempenhaeghe | Recruiting | Heeze | North Brabant | 5591 VE | Netherlands |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 |
| Stichting Epilepsie Instellingen Nederland | Recruiting | Heemstede | North Holland | 2103 SW | Netherlands |
|
| Maasstad ziekenhuis | Recruiting | Rotterdam | South Holland | 3079 DZ | Netherlands |
|
| University Medical Center Utrecht | Recruiting | Utrecht | Netherlands |
|