Recruiting

Seizure Risk Tool

Sponsor:

Empatica, Inc.

Code:

NCT06275685

Conditions

Epilepsy; Seizure

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

SeizureWise algorithm

Multi-day Visualizations

Study Details

Brief summary:

The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy.

The main questions it aims to answer are:

  • can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables.
  • does this tool improve the lives of people with epilepsy?

Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.

Conditions

Epilepsy; Seizure

Study ID

NCT06275685

Start date

Apr 11, 2024

Status verified date

Sep, 2024

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects must be diagnosed with or be at risk of epilepsy
  • Subjects or their parents or guardians must understand and consent to be in the study;
  • Subjects or their parents or guardians must be able to read and communicate in English;
  • Subjects or their parents or guardians must be willing and able to comply with study procedures and duration;
  • Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.

Exclusion Criteria:

  • Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks;
  • Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary);
  • Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or
  • Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms.

Study Design

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Control

The control arm will receive multi-day visualizations of their sensor derived data but not receive SeizureWise

experimental: Personalized seizure risk score

The personalized seizure risk score arm will receive multi-day visualization of their sensor derived data and also SeizureWise, an investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables

Interventions

SeizureWise algorithm

An investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables

Multi-day Visualizations

Multi-day visualizations of sensor derived data

Primary outcome measure

  • Sensitivity of SeizureWise [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Empatica Support

855-830-3531support@empatica.com

Locations

Empatica

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Empatica

855-830-3531support@empatica.com

More Information

Sponsor

Empatica, Inc.

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • forecasting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Empatica, Inc. on 2024-09-19.