Clinical trial NCT06275685: Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking
Official title: Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy; Seizure
Keywords: forecasting
Lead sponsor: Empatica, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-23
Enrollment: 3000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Sensitivity of SeizureWise
timeFrame: 2 years
Secondary outcomes:
measure: Change in QoL and psychological health indicators using the Quality of life in epilepsy (QOLIE-10-P)
timeFrame: 2 years
measure: Qualitative assessment of multi-day visualizations
timeFrame: 2 years
measure: Stress level with visualizations using the brief epilepsy anxiety survey instrument (brEASI-8)
timeFrame: 2 years
measure: Modifiable behavior change
timeFrame: 2 years
measure: Accuracy of SeizureWise low-likelihood forecast
timeFrame: 2 years
measure: Accuracy of SeizureWise high-likelihood forecast
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Empatica
state: Massachusetts
Study officials:
References: