Seizure Detection and Warning System in Epilepsy Patients

Brain Sentinel

Status: Completed

Conditions: Generalized Tonic-Clonic Seizures; Epilepsy

Treatments: Device: Brain Sentinel Seizure Detection and Warning System

Study type: Observational

Funder types: Other

Identifiers

NCT02555410

3.01P

Details and patient eligibility

About

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.

Full description

The Brain Sentinel™ Seizure Detection and Warning System is intended for monitoring children and adults with a history or significant risk of generalized tonic-clonic seizures in the home or healthcare facilities, during the titration or withdrawal of anti-epileptic drugs, and for continuous monitoring (night time or any other time of day) of individuals due to their history or risk of generalized tonic-clonic seizures. The device will withstand activities of daily living including showers and sleep.

Enrollment: 11 patients

Sex: All

Ages: 2 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization.
2. Male or female between the ages of 2-99.
3. Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 14cm).
4. Be able to tolerate wearing the device on the upper arm.
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. The subject's upper arm circumference not adequate for proper fit of the EMG monitor (less than 14cm)
3. Pregnant female
4. Subject/Caregiver is unable to provide consent.
5. Subject/Caregiver is not competent to follow home study procedures.
6. The subject is homeless or in a home without a power supply.

Trial design

11 participants in 1 patient group

Brain Sentinel Seizure Detection and Warning System

Description:

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

Treatment:

Device: Brain Sentinel Seizure Detection and Warning System