Smartphone Behavior and Epilepsy Management

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

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

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Change in touchscreen interactions

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Arthur R van Nieuw Amerongen; Phone Number: +31235588018; Email: avnieuwamerongen@sein.nl

Study Locations

• Netherlands
  • Utrecht, Netherlands
    • Recruiting
    • University Medical Center Utrecht
    • Contact: Frans SS Leijten, MD, PhD; Phone Number: +31 88 75 579 89; Email: policvz@umcutrecht.nl
  • Noord-Brabant
    • Heeze, Noord-Brabant, Netherlands, 5591 VE
      • Recruiting
      • Kempenhaeghe
      • Contact: Richard Lazeron, MD PhD; Email: LazeronR@Kempenhaeghe.nl
      • Principal Investigator: Richard Lazeron, MD PhD
  • Noord-Holland
    • Heemstede, Noord-Holland, Netherlands, 2103 SW
      • Recruiting
      • Stichting Epilepsie Instellingen Nederland
      • Principal Investigator: Roland D Thijs, MD PhD
      • Contact: Arthur R van Nieuw Amerongen; Phone Number: +31235588018; Email: avnieuwamerongen@sein.nl
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3079 DZ
      • Recruiting
      • Maasstad Ziekenhuis
      • Contact: Barbara Kuijper, MD PhD; Email: KuijperB@maasstadziekenhuis.nl
      • Principal Investigator: Evert Kaal, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

100 subjects with refractory focal epilepsy with a seizure frequency of at least one per month.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Change in touchscreen interactions; The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Stichting Epilepsie Instellingen Nederland
• Collaborators: Leiden University
• Investigators: Principal Investigator: Roland D Thijs, MD PhD, Stichting Epilepsie Instellingen Nederland

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: SB&EM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No