Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in 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 (System Version 1.5) in Epilepsy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371200
• Other study ID #: GTC-1.5-09.2015
• Status: Completed
• Start date: April 2015
• Est. completion date: February 2018

Study information

• Verified date: July 2018
• Source: Brain Sentinel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.

Description:

This study "A Pivotal, Phase III Trial of Detecting generalized tonic-clonic seizures with a Seizure Detection and Warning System in Epilepsy Patients " is a phase III, pivotal, prospective study of an electromyography (EMG) based seizure detection and warning system (tentatively named Brain Sentinel™ Seizure Detection System) for detecting generalized tonic-clonic (GTC) seizures. The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity. This is to facilitate a faster intervention to the GTC seizure, and to more accurately document GTC seizure frequency in a home, skilled nursing, or inpatient setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Subject has a 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 2-99.

4. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).

5. If female and of childbearing potential, has a negative pregnancy test.

6. 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.

7. Subject and/or Primary Caregiver must be competent to follow all study procedures.

8. Is able to read, speak, and understand English.

Exclusion Criteria:

1. Does not have a documented history of generalized seizures.

2. 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.

3. Intracranial EEG electrodes are being used

4. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).

5. Pregnant female.

6. Subject/Caregiver is unable to provide consent.

Related Conditions & MeSH terms

• Epilepsy
• Generalized Tonic-Clonic Seizures
• Seizures

Intervention

Device:
• Brain Sentinel Seizure Detection and Warning System
The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University Hospital	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	Sensitivity of the Seizure Detection System	The primary outcome measure for this clinical trial will be the sensitivity of the Brain Sentinel™ Seizure Detection Systems ability to detect GTC seizure activity in comparison to a Neurologist independent review of vEEG collected in an epilepsy monitoring unit.	up to 1 month