Forecasting seizures using wearable technology
Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking
This study is testing a new wearable device that helps people with epilepsy predict when they might have a seizure to see if it improves their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Empatica, Inc. Industry-sponsored |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06275685 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to develop a personalized tool for predicting seizure risks in individuals with epilepsy by analyzing patterns from previous generalized tonic-clonic seizures (GTCS) and physiological data collected through a wearable device. Participants will be divided into two groups: one with access to the seizure forecasting tool and one without, to evaluate the tool's accuracy and its impact on quality of life. The study will also assess the clinical outcomes related to psychological health and economic factors. The research involves a randomized, open-label design to ensure comprehensive evaluation of the tool's effectiveness.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with epilepsy or those at risk of developing it, who can understand and consent to participate in the study.
Not a fit: Patients who are cognitively or physically unable to engage in study activities or who do not understand the study's risks may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly enhance the quality of life for patients with epilepsy by providing timely seizure forecasts.
How similar studies have performed: While the approach of using wearable technology for seizure forecasting is innovative, similar studies have shown promise in utilizing technology for health tracking and seizure management.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Empatica — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Empatica Support
- Email: support@empatica.com
- Phone: 855-830-3531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.