We 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 we evaluate epilepsy treatments in daily…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in touchscreen interactions (tapping speed, texting speed, apps used,
location, sleep-wake cycles) surrounding reported epileptic seizures.
Secondary outcome
Niet van toepassing
Background summary
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.
Study objective
We 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 we evaluate epilepsy
treatments in daily practice.
Study design
Observational prospective cohort study with 3 months follow-up.
Study burden and risks
As this concerns observational research, no direct risk is involved with
participation in this study. All app data will be encrypted before being send
into the cloud, to minimize risk of privacy violation.
Achterweg 3
Heemstede 2103 SW
NL
Achterweg 3
Heemstede 2103 SW
NL
Listed location countries
Age
Inclusion criteria
- >= 18 years of age
- clinical diagnosis of refractory focal epilepsy meeting ILAE criteria
- 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
- gave informed consent
Exclusion criteria
not fulfilling the above mentioned inclusion criteria
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70839.058.19 |