Smartphone Behavior and Epilepsy Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-03

Study Completion Date

2023-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Change in touchscreen interactions

Intervention Type BEHAVIORAL

The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions

Interventions

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Change in touchscreen interactions

The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No