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Trial record 1 of 17 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 March 2017 by Brain Sentinel
Sponsor:
Information provided by (Responsible Party):
Brain Sentinel
ClinicalTrials.gov Identifier:
NCT01874600
First received: June 5, 2013
Last updated: March 23, 2017
Last verified: March 2017
June 5, 2013
March 23, 2017
July 2013
December 2017   (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
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.
 
Recruiting
225
December 2017
December 2017   (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.
Sexes Eligible for Study: All
2 Years to 99 Years   (Child, Adult, Senior)
No
Contact: Kaylee Touchstone, AA 855-275-5424 ext 109 kaylee.touchstone@brainsentinel.com
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
March 2017

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