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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 12, 2023

Status Verified

June 1, 2022

Enrollment Period

3.1 years

First QC Date

October 28, 2020

Last Update Submit

April 11, 2023

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Recovery after seizure

    3 months

  • Comparison of seizures in diaries and seizures in app use

    3 months

  • Subgroup analysis

    3 months

Study Arms (1)

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

Interventions

Change in touchscreen interactionsBEHAVIORAL

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

subjects with refractory focal epilepsy with a seizure frequency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • ≥ 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kempenhaeghe

Heeze, North Brabant, 5591 VE, Netherlands

RECRUITING

Stichting Epilepsie Instellingen Nederland

Heemstede, North Holland, 2103 SW, Netherlands

RECRUITING

Maasstad ziekenhuis

Rotterdam, South Holland, 3079 DZ, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Roland D Thijs, MD PhD

    Stichting Epilepsie Instellingen Nederland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur R van Nieuw Amerongen

CONTACT

+31235588018avnieuwamerongen@sein.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 5, 2020

Study Start

November 3, 2020

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

April 12, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(4)