Smartphone Behavior and Epilepsy Management

Epilepsy Clinical Trial

Official title:

Using Day-to-day Behavior on Smartphones to Improve Epilepsy Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04617418
• Other study ID #: SB&EM
• Status: Recruiting
• Start date: November 3, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2022
• Source: Stichting Epilepsie Instellingen Nederland
• Contact: Arthur R van Nieuw Amerongen
• Phone: +31235588018
• Email: avnieuwamerongen[@]sein.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• Change in touchscreen interactions
The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions

Locations

Country	Name	City	State
Netherlands	Stichting Epilepsie Instellingen Nederland	Heemstede	Noord-Holland
Netherlands	Kempenhaeghe	Heeze	Noord-Brabant
Netherlands	Maasstad ziekenhuis	Rotterdam	South Holland
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Stichting Epilepsie Instellingen Nederland	Leiden University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in tapping speed surrounding reported epileptic seizures	The tapping speed will be measured using the TapCounter app by QuantActions	3 months
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	Comparison of seizures in diaries and seizures in app use	See if reported seizure incidence matches with seizure incidence deducted from smartphone measurements	3 months
Secondary	Subgroup analysis	Analyze differences in behavioural patterns between individuals with different types of epilepsy (e.g. different seizure types or onset zones)	3 months