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Seizure Detection and Warning System for Epilepsy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01874600
Recruitment Status : Active, not recruiting
First Posted : June 11, 2013
Last Update Posted : July 10, 2019
Information provided by (Responsible Party):
Brain Sentinel

Brief 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.

Condition or disease Intervention/treatment
Epilepsy Device: Brain Sentinel Seizure Detection Device and Warning System

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Study Type : Observational
Actual Enrollment : 239 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
Study Start Date : July 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Group/Cohort Intervention/treatment
Epilepsy Patients
This study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG.
Device: Brain Sentinel Seizure Detection Device and Warning System
The Brain Sentinel Seizure Detection Device and Warning System is designed to monitor Epilepsy patients and alerts caregivers that a GTC seizure is occurring

Primary Outcome Measures :
  1. Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG. [ Time Frame: less than 1 month ]
    The primary objective of the research is to determine the ability of the Brain Sentinel Seizure Detection System to accurately detect GTC seizures in comparison to the recognized "gold standard" for seizure detection, video Electroencephalography (vEEG).The primary endpoint will be the sensitivity of GTC seizure detection (defined as within 30 seconds of motor manifestation via vEEG analysis) in a hospital setting.

Secondary Outcome Measures :
  1. Comparison of study device to self reporting of seizures using a seizure diary. [ Time Frame: Less than 1 month ]
    The secondary objective is to assess the operation of the Brain Sentinel Seizure Detection System when used in the subject's home and to compare the GTC seizure reporting of the device to a standard seizure diary completed by the subject/caregiver.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   13 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adolescent epilepsy patients with a history of generalized tonic-clonic seizures either primary GTC or partial onset seizures with second generalization.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01874600

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United States, Texas
Brain Sentinel
San Antonio, Texas, United States, 78232-1399
Sponsors and Collaborators
Brain Sentinel
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Principal Investigator: Jose' E Cavazos, MD, PhD Brain Sentinel
Principal Investigator: Dennis Dlugos, MD Children's Hospital of Philadelphia
Principal Investigator: Jonathan Halford, MD Medical University of South Carolina
Principal Investigator: Dileep Nair, MD The Cleveland Clinic
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Responsible Party: Brain Sentinel Identifier: NCT01874600    
Other Study ID Numbers: BS-0421
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations