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Seizure Detection and Warning System for Epilepsy Patients | Clinical Trials | Clareo Health

UNKNOWN

Seizure Detection and Warning System for Epilepsy Patients

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

NCT01874600•Brain Sentinel

View on ClinicalTrials.gov

Summary

The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.

Eligibility

Age

13 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has a suspected history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
•2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
•3. Male or female between the ages of 13-21.
•4. If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
•5. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
•6. Subject and/or Primary Caregiver must be competent to follow all study procedures.
•7. Is able to read, speak, and understand English or has a LAR that does so.
•8. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

Exclusion Criteria

•1. Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
•2. Intracranial EEG electrodes are being used.
•3. The subject is allergic to adhesives or any component of the electrode patch assembly

Locations (1)

Brain Sentinel

San Antonio, Texas, United States

Key Dates

Start Date

July 1, 2013

Primary Completion Date

December 1, 2019

Completion Date

December 1, 2019

Last Updated

July 10, 2019

Enrollment

239

ACTUAL participants

Conditions

Epilepsy

Interventions

Brain Sentinel Seizure Detection Device and Warning System

DEVICE

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

View study

RECRUITINGPHASE1

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

NCT02531880

Epilepsy

View study

RECRUITINGNA

Intracranial Investigation of Neural Circuity Underlying Human Mood

NCT05871372

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Seizure Detection and Warning System for Epilepsy Patients

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

MEHMO Natural History and Biomarkers