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
Study 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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Sensitivity of SeizureWise — 2 years Percentage of patients with (1) sensitivity of high-likelihood warnings greater than 60% and (2) superior to a rate-matched forecast (or superior baselining method) at the end of Phase 2.
Trial sites (1)
Facility
City
Region
Status
Empatica
Boston
Massachusetts
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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