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Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

NCT06275685 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

  • Epilepsy; Seizure

Interventions

DEVICE

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

DEVICE

Multi-day Visualizations

Multi-day visualizations of sensor derived data

Sponsors & Collaborators

  • Empatica, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-11
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06275685 on ClinicalTrials.gov