Smartphone Behavior and Epilepsy Management

Stichting Epilepsie Instellingen Nederland

Status: Enrolling

Conditions: Epilepsy

Treatments: Behavioral: Change in touchscreen interactions

Study type: Observational

Funder types: Other

Identifiers

NCT04617418

SB&EM

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

subjects with refractory focal epilepsy with a seizure frequency

Description:

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.

Treatment:

Behavioral: Change in touchscreen interactions