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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


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04617418
Study type Observational
Source Stichting Epilepsie Instellingen Nederland
Contact Arthur R van Nieuw Amerongen
Phone +31235588018
Email avnieuwamerongen@sein.nl
Status Recruiting
Phase
Start date November 3, 2020
Completion date December 31, 2023

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