Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Empatica, Inc.
Study ID
NCT06275685
Status
Recruiting
Apply to this trial

Conditions

  • Epilepsy; Seizure

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SeizureWise algorithm — DEVICE
    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
  • Multi-day Visualizations — DEVICE
    Multi-day visualizations of sensor derived data

Study Details

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.

Key Dates

Start date
Apr 11, 2024
Status verified
Sep 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
3,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Control
    The control arm will receive multi-day visualizations of their sensor derived data but not receive SeizureWise
  • Experimental: Personalized seizure risk score
    The personalized seizure risk score arm will receive multi-day visualization of their sensor derived data and also SeizureWise, 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

Primary Outcome Measure

Sensitivity of SeizureWise [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
EmpaticaBostonMassachusetts02111
Empatica
[email protected]
855-830-3531

Find similar trials in Boston, MA

By research site
Empatica· Boston, MA

Related Studies