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Recruiting NCT06275685

Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

No phase Interventional Epilepsy; Seizure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SeizureWise algorithm, Multi-day Visualizations.
Who it may be relevant to
Registry conditions: Epilepsy; Seizure. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking

Overview

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.

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

Primary outcome measures

  • Sensitivity of SeizureWise [Time frame: 2 years]
Secondary outcome measures (6)
  • Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P) [Time frame: 2 years]
  • Qualitative assessment of multi-day visualizations [Time frame: 2 years]
  • Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8) [Time frame: 2 years]
  • Modifiable behavior change [Time frame: 2 years]
  • Accuracy of SeizureWise low-likelihood forecast [Time frame: 2 years]
  • Accuracy of SeizureWise high-likelihood forecast [Time frame: 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Empatica — Boston

Identifiers

NCT: NCT06275685 · CIP-0001510

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗