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
  Purpose

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 Intervention Phase
Epilepsy
Device: Brain Sentinel Seizure Detection Device and Warning System
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

Resource links provided by NLM:


Further study details as provided by Brain Sentinel:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 225
Study Start Date: July 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Brain Sentinel Seizure Detection Device and Warning System

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874600

Contacts
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

Locations
United States, Texas
Brain Sentinel Recruiting
San Antonio, Texas, United States, 78232-1399
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   
Sponsors and Collaborators
Brain Sentinel
Investigators
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
  More Information

No publications provided

Responsible Party: Brain Sentinel
ClinicalTrials.gov Identifier: NCT01874600     History of Changes
Other Study ID Numbers: BS-0421
Study First Received: June 5, 2013
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014