Seizure Detection and Warning System in Epilepsy Patients

Completed

Conditions studied: Epilepsy, Generalized Tonic-Clonic Seizures

In brief

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.

Key facts

Study ID

NCT02555410

Run by

Brain Sentinel

People needed

11

Starts

2013-01-01

Expected to finish

2017-07-07

Last updated by the study team

2017-07-12

Who can join

Age: 2 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Jose' E. Cavazos — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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