Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking (Foresight)

Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy; Seizure
• Intervention / Treatment: Device: Multi-day Visualizations; Device: SeizureWise algorithm

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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Empatica; Phone Number: 855-830-3531; Email: support@empatica.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; The control arm will receive multi-day visualizations of their sensor derived data but not receive SeizureWise	Device: Multi-day Visualizations; Multi-day visualizations of sensor derived data
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	Device: Multi-day Visualizations; Multi-day visualizations of sensor derived data; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of SeizureWise	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P)	Changes in QoL and psychological health indicators pre- and post-Phase 3 (cross-arm and intra-arm comparisons. This will be assessed using the QOLIE-10-P and scored according to these guidelines https://www.aan.com/siteassets/home-page/policy-and-guidelines/quality/quality-measures/epilepsy-and-seizures/qolie10p-scoring.pdf	2 years
Qualitative assessment of multi-day visualizations	Patient-reported qualitative assessment of multi-day visualizations to the patient during Phase 3 (both arms). This will be assessed using a custom survey and a qualitative analysis of the scores will be performed between start of phase 3 (with no visualizations) and during and at the end of phase 3 when visualizations have been provided to the user.	2 years
Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8)	Quantitative patient report of stress level pre- and post- forecast visualization during Phase 3 in the intervention arm. This will be assessed using brEASI-8 where a lower score indicates a lower stress level.	2 years
Modifiable behavior change	Adjustment in modifiable behaviors during Phase 3 based on multi-day visualizations (boths arms) and forecast outputs (intervention arm). This will be assessed using a custom survey and a qualitative analysis will be performed that looks at participants behaviors before and after receiving visualizations and SeizureWise.	2 years
Accuracy of SeizureWise low-likelihood forecast	Percentage of time in a low-likelihood forecast category during which no seizure event occurs during Phase 2.	2 years
Accuracy of SeizureWise high-likelihood forecast	Percentage of time in a high-likelihood forecast category during which a seizure event occurs during Phase 2.	2 years

Collaborators and Investigators

• Sponsor: Empatica, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Estimated): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: forecasting
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: CIP-0001510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No