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Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients | Clinical Trials | Clareo Health

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Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System (System Version 1.5) in Epilepsy Patients

NCT02371200•Brain Sentinel

View on ClinicalTrials.gov

Summary

Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.

Detailed Description

This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal, prospective study of an electromyography (EMG) based seizure detection and warning system (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized tonic-clonic (GTC) seizures. The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity. This is to facilitate a faster intervention to the GTC seizure, and to more accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting.

Eligibility

Age

2 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has a 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 2-99.
•4. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
•5. If female and of childbearing potential, has a negative pregnancy test.
•6. 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.
•7. Subject and/or Primary Caregiver must be competent to follow all study procedures.
•8. Is able to read, speak, and understand English.

Exclusion Criteria

•1. Does not have a documented history of generalized seizures.
•2. 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.
•3. Intracranial EEG electrodes are being used
•4. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
•5. Pregnant female.
•6. Subject/Caregiver is unable to provide consent.

Locations (2)

Medical University of South Carolina

Charleston, South Carolina, United States

University Hospital

San Antonio, Texas, United States

Key Dates

Start Date

April 1, 2015

Primary Completion Date

December 1, 2017

Completion Date

February 1, 2018

Last Updated

July 10, 2018

Enrollment

ACTUAL participants

Conditions

EpilepsyGeneralized Tonic-Clonic Seizures

Interventions

Brain Sentinel Seizure Detection and Warning System

DEVICE

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

View study

RECRUITINGPHASE3

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

NCT05667142

Primary Generalized Tonic-Clonic Seizures

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RECRUITINGPHASE1

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

NCT02531880

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, 2018Data 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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Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

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