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

NCT02371200 | Completed

• 1 other identifier: GTC-1.5-09.2015
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Epilepsy; Generalized Tonic-Clonic Seizures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Brain Sentinel Seizure Detection and Warning System

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 and Warning System

Interventions

Brain Sentinel Seizure Detection and Warning System DEVICE

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.

Also known as: SPEAC System

Brain Sentinel Seizure Detection and Warning System

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children and Adults with GTC seizures, either primary GTC or partial onset seizures with secondary generalization

You may qualify if:

• Subject has a 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 2-99.
• Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
• If female and of childbearing potential, has a 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.
• Is able to read, speak, and understand English.

You may not qualify if:

• 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
• The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm).
• Pregnant female.
• Subject/Caregiver is unable to provide consent.

Sponsors & Collaborators

• Brain Sentinel: lead

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Szabo, MD

  University Health System of San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 25, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)