We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 17 for:    seizure detection device
Previous Study | Return to List | Next Study

Seizure Detection and Warning System for Epilepsy Patients

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01874600
First Posted: June 11, 2013
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Brain Sentinel
June 5, 2013
June 11, 2013
October 12, 2017
July 2013
December 2018   (Final data collection date for primary outcome measure)
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.
Seizure detection and warning [ Time Frame: Less than one month for each subject ]
Determine the ability of the seizure detection device to accurately detect GTC seizures in comparison to the recognized "gold standard" for seizure detection, video Electroencephalography (vEEG).
Complete list of historical versions of study NCT01874600 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Adolescent epilepsy patients with a history of generalized tonic-clonic seizures either primary GTC or partial onset seizures with second generalization.
Epilepsy
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
Epilepsy Patients
This study will compare accuracy of seizure detection by the study device to simultaneously collected data of seizure detection by video EEG.
Intervention: Device: Brain Sentinel Seizure Detection Device and Warning System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
278
December 2018
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
13 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01874600
BS-0421
No
Not Provided
Plan to Share IPD: No
Brain Sentinel
Brain Sentinel
Not Provided
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
Brain Sentinel
October 2017