Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

Официальное название

Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство Multi-day Visualizations
  Multi-day visualizations of sensor derived data

Первичные конечные точки

• Sensitivity of SeizureWise [Срок оценки: 2 years]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Empatica — Boston

Идентификаторы

NCT: NCT06275685 · CIP-0001510

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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