Forecasting Seizures Using Intelligent Wearable Technology

This study is testing a new tool called SeizureWise, which is an algorithm designed to predict future seizure probabilities. It uses information from your past generalized tonic-clonic seizures (GTCS) and changes in your body's signals and behaviors, collected by a wearable device. Researchers want to see if SeizureWise can accurately forecast seizures and if having access to this information improves the lives of people with epilepsy. You could join if you are 6 years or older, have epilepsy or are at risk, and can understand and agree to the study procedures. The study aims to enroll 3000 participants.

Study design: This is an interventional study where participants will be randomly assigned to different groups. It is an open-label study, meaning both you and the researchers will know which intervention you are receiving.
What's involved: You will use a wearable EmbracePlus device and provide data. The study will involve two phases where the algorithm is developed and tested, followed by a final phase where you might have access to a seizure forecasting risk score.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome, the sensitivity of SeizureWise, will be measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

Recruiting

NAAges 6+Interventional

Empatica, Inc.

~3,000 participants

Updated 2024-09-19 on ClinicalTrials.gov

What's tested:SeizureWise algorithmMulti-day Visualizations

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Sensitivity of SeizureWise

Measured over 2 years

Conditions

Epilepsy; Seizure

Where it's being run

1 sites across 1 states

Massachusetts1

Who to contact

Empatica Support

[email protected]

855-830-3531

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Sensitivity of SeizureWise2 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.

Trialytics