Seizure Detection and Warning System in Epilepsy Patients

NCT02555410 | Completed

• 1 other identifier: 3.01P
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.

Conditions

Epilepsy; Generalized Tonic-Clonic Seizures

Outcome Measures

Primary Outcomes (1)

• Test the function of the system including ability to acquire EMG signal, analyze and successfully transmit the analysis to the base station, and identify and transmit all alert conditions.

  The overall usability and technical features will be assessed through questionnaires and surveys as the Seizure Detection and Warning System will be used within a home setting.

  up to 1 month

Secondary Outcomes (1)

• Compare the accuracy of the EMG based system's log to the subject's seizure diary

  up to one month

Study Arms (1)

Brain Sentinel Seizure Detection and Warning System

To test the usability of the Brain Sentinel Seizure Detection and Warning System(also known as the SPEAC system) in a patient home setting.

Device: Brain Sentinel Seizure Detection and Warning System

Interventions

Brain Sentinel Seizure Detection and Warning System DEVICE

A sEMG based automated seizure detection and warning system worn on the biceps

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

Subjects with a history of 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.
• 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).
• Be able to tolerate wearing the device on the upper arm.
• 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.
• 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.
• Subject/Caregiver is not competent to follow home study procedures.
• The subject is homeless or in a home without a power supply.

Sponsors & Collaborators

• Brain Sentinel: lead

Study Sites (1)

Jose' E. Cavazos

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

• Jose E. Cavazos, MD, PhD

  Brain Sentinel

  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: September 21, 2015
• Study Start: January 1, 2013
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: July 12, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)