Epilepsy
Conditions
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.
Interventions
BEHAVIORALChange in touchscreen interactions
The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions
Sponsors
Leiden University
Stichting Epilepsie Instellingen Nederland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Countries
Netherlands
Contacts
Primary ContactArthur R van Nieuw Amerongen
Outcome results
None listed