Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT04617418
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.
Study:
NCT04617418
Study Brief:
Protocol Section:
NCT04617418