Clinical trial NCT02555410: Seizure Detection and Warning System in Epilepsy Patients
Official title: A Pivotal, Phase II Trial of Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Generalized Tonic-Clonic Seizures
Lead sponsor: Brain Sentinel
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 11
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a history of GTC seizures, either primary GTC or partial onset seizures with secondary generalization

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: up to 1 month
Secondary outcomes:
measure: Compare the accuracy of the EMG based system's log to the subject's seizure diary
timeFrame: up to one month
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Jose' E. Cavazos
state: Texas
Study officials:
affiliation: Brain Sentinel
name: Jose E. Cavazos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: