Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06275685
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-02-08
Brief Title:
Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking
Sponsor:
Empatica Inc
Organization:
Empatica Inc
Study Overview
Official Title:
Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Foresight
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None