Seizure Detection and Warning System for Epilepsy Patients

NCT01874600 | Unknown

• 1 other identifier: BS-0421
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Primary outcome is accuracy of device to detect GTC seizures when compared to video EEG.

  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.

  less than 1 month

Secondary Outcomes (1)

• Comparison of study device to self reporting of seizures using a seizure diary.

  Less than 1 month

Study Arms (1)

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

Interventions

Brain Sentinel Seizure Detection Device and Warning System DEVICE

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

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Subject has a suspected history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
• Is being admitted to a hospital for routine vEEG monitoring related to seizures.
• Male or female between the ages of 13-21.
• If female and of childbearing potential, has a negative pregnancy urine test, and must also not be nursing.
• 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.
• Is able to read, speak, and understand English or has a LAR that does so.
• Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

You may not qualify if:

• 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.
• The subject is allergic to adhesives or any component of the electrode patch assembly

Sponsors & Collaborators

• Brain Sentinel: lead

Study Sites (1)

Brain Sentinel

San Antonio, Texas, 78232-1399, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 11, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)