Clinical trial NCT04617418: Smartphone Behavior and Epilepsy Management
Official title: Using Day-to-day Behavior on Smartphones to Improve Epilepsy Management
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Lead sponsor: Stichting Epilepsie Instellingen Nederland
Sponsor class: OTHER
Collaborators: name: Leiden University
First posted: 2020-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in tapping speed surrounding reported epileptic seizures
timeFrame: 3 months
measure: Changes in number of apps used surrounding reported epileptic seizures
timeFrame: 3 months
measure: Changes in time spent using the smartphone surrounding reported epileptic seizures
timeFrame: 3 months
measure: Changes in speed of unlocking the smartphone surrounding reported epileptic seizures
timeFrame: 3 months
Secondary outcomes:
measure: Recovery after seizure
timeFrame: 3 months
measure: Comparison of seizures in diaries and seizures in app use
timeFrame: 3 months
measure: Subgroup analysis
timeFrame: 3 months
Other outcomes:
Locations:
city: Heeze
country: Netherlands
facility: Kempenhaeghe
state: Noord-Brabant
city: Heemstede
country: Netherlands
facility: Stichting Epilepsie Instellingen Nederland
state: Noord-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad ziekenhuis
state: South Holland
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Stichting Epilepsie Instellingen Nederland
name: Roland D Thijs, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: