Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking
Recruiting · NCT06275685 · Interventional (participants receive a specific treatment) · Lead sponsor: Empatica, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Empatica - Boston, Massachusetts, United States