Trial record 1 of 15 for:    seizure detection device
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Seizure Detection and Warning System for Epilepsy Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Brain Sentinel
Sponsor:
Information provided by (Responsible Party):
Brain Sentinel
ClinicalTrials.gov Identifier:
NCT01874600
First received: June 5, 2013
Last updated: September 11, 2014
Last verified: September 2014

June 5, 2013
September 11, 2014
July 2013
January 2015   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Epilepsy
Device: Brain Sentinel Seizure Detection Device and Warning System
Epilepsy Patients
This study has no arms, but 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.
 
Recruiting
225
February 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have a history of generalized tonic-clonic seizures, either primary GTC or partial onset seizures with 2nd generalization.
  • Be admitted to a hospital for routine vEEG monitoring related to seizures.
  • Be ages 2-99.
  • Have an upper arm circumference which is adequate for proper fit of the EMG monitor or the monitor with arm adapter (approximately 16 cm).
  • Be able to be discharged to a home with electrical power supply.
  • Be able to be discharged to a home where internet service via phone, broadband, satellite or cellular phone service can be provided.
  • If female and of childbearing potential, have negative pregnancy test.
  • 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.
  • Subject and/or Primary Caregiver must be competent to follow all study procedures.
  • Able to read, speak, and understand English.

Exclusion Criteria:

  • Does not have a documented history of generalized seizures.
  • 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.
  • Intracranial EEG electrodes are being used
  • Upper arm circumference not adequate for proper fit of the EMG monitor even if the arm adapter is used (less than approximately 16cm).
  • If female, is pregnant.
  • Subject or Caregiver are unable to provide consent.
  • Subject or Caregiver not competent to follow home study procedures.
  • Homeless or home without power supply.
  • Resides in a home where internet service via phone, broadband, satellite or cellular phone service cannot be provided.
  • Subject or Caregiver is unable to read, speak, or understand English.
Both
2 Years and older
No
Contact: Rose Hernandez, BS 855-275-5424 ext 107 rose.hernandez@brainsentinel.com
Contact: Kaylee A Touchstone, AA 855-275-5424 kaylee.touchstone@brainsentinel.com
United States
 
NCT01874600
BS-0421
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: Jaqueline French, MD NYU Comprehensive Epilepsy Center
Principal Investigator: Edward Faught, MD Emory University
Principal Investigator: William Tatum, DO Mayo Clinic Jacksonville Florida
Principal Investigator: Katherine Noe, MD Mayo Clinic Phoenix Arizona
Principal Investigator: Jonathan Halford, MD Medical University of South Carolina
Principal Investigator: Jay Harvey, DO Texas Health Presbyterian Hospital Dallas, Texas
Principal Investigator: Michael Sperling, MD Thomas Jefferson University
Principal Investigator: John Pollard, MD University of Pennsylvania
Principal Investigator: Thomas R Henry, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Dileep Nair, MD The Cleveland Clinic
Brain Sentinel
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP