Epilepsy; Seizure Clinical Trial
Official title:
Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking
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 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03548779 -
North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2
|
N/A | |
Completed |
NCT05605301 -
Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy
|
Phase 2 | |
Completed |
NCT05257811 -
Earbud EEG Feasibility Study
|
||
Completed |
NCT05066880 -
Yoga and Aerobic Exercise in Epilepsy
|
N/A | |
Recruiting |
NCT06278428 -
Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age
|
||
Terminated |
NCT04639310 -
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
|
Phase 3 | |
Withdrawn |
NCT04737174 -
ES-481 for Uncontrolled Glioma-Associated Epilepsy and Assessment for Potential Anti-Tumorigenic Effect in Patients With Isocitrate Dehydrogenase 1 (IDH1) Mutant Tumors
|
Phase 2 | |
Completed |
NCT04822662 -
The Individual and Family Self Management Theory Based Epilepsy Education Program's Effectiveness
|
N/A | |
Recruiting |
NCT04759196 -
Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas
|
Phase 4 | |
Completed |
NCT04171934 -
Clinical Validation of a Video-based Epilepsy Examination Service
|
||
Recruiting |
NCT04569708 -
Sleep Spindles and Memory in Rolandic Epilepsy
|
N/A | |
Completed |
NCT04311151 -
Impact of Self-visualization of Epileptic Seizures on Patients' Perception of the Disease and Risk Behavior
|
N/A | |
Not yet recruiting |
NCT05635396 -
Seizures Detection in Real Life Setting
|
N/A | |
Completed |
NCT05675254 -
The Prevalence and Risk Factors of Coagulopathy in Pediatric Epilepsy Surgery Patients
|
||
Terminated |
NCT04912856 -
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
|
Phase 3 | |
Recruiting |
NCT04221282 -
ZEBinix® Retention Rate in Epilepsy in Elderly Patients
|