Seizure Detection and Warning System for Epilepsy Patients

Epilepsy Clinical Trial

Official title:

A Pivotal, Phase III Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01874600
• Other study ID #: BS-0421
• Status: Active, not recruiting
• Start date: July 2013
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Brain Sentinel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 239
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

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

Locations

Country	Name	City	State
United States	Brain Sentinel	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brain Sentinel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of study device to self reporting of seizures using a seizure diary.	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.	Less than 1 month