Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

NCT ID: NCT06275685

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2026-06-30

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.

Detailed Description

The primary goal of the study is to demonstrate the accuracy of SeizureWise in predicting the timing of future convulsive seizures using data collected by the wearable EmbracePlus device and data provided by patients with GTCS monitored in outpatient settings.

The secondary goals are:

to assess the clinical impact of SeizureWise on quality of life (QoL), psychological health indicators, and economic and clinical outcomes to assess the clinical impact of visualizing behavioral and physiologic data without forecasting predictions on quality of life (QoL), psychological health indicators, and economic and clinical outcomes

A non-significant risk, open-label, prospective, randomized clinical investigation designed to evaluate the ability of SeizureWise to forecast GTCS occurrence and to assess impact on QoL and seizure management outcomes.

The study will include two phases during which an algorithm based on sensor derived physiological measures is developed and tested with output blinded to the participant. In a final phase participants will be randomized to two arms, one of which will have access to a seizure forecasting risk score.

Conditions

Epilepsy; Seizure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: ACTIVE_COMPARATOR

Multi-day Visualizations

Intervention Type: DEVICE

Multi-day visualizations of sensor derived data

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

Group Type: EXPERIMENTAL

SeizureWise algorithm

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Multi-day visualizations of sensor derived data

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

Intervention Type: DEVICE

Multi-day Visualizations

Multi-day visualizations of sensor derived data

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Empatica, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Empatica

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Empatica Support

Role: CONTACT

support@empatica.com

855-830-3531

Facility Contacts

Empatica

Role: primary

support@empatica.com

855-830-3531

Other Identifiers

CIP-0001510

Identifier Type: -

Identifier Source: org_study_id