Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Empatica
RECRUITING
Boston
Contact Information
Primary
Empatica Support
support@empatica.com
855-830-3531
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2026-06
Participants
Target number of participants: 3000
Treatments
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
Sponsors
Leads: Empatica, Inc.

This content was sourced from clinicaltrials.gov