A Health Economic Study Evaluating the Brain Sentinel® GTC Seizure Detection and Information Systems Impact on Epilepsy and Healthcare Utilization

Stopped early

Conditions studied: Epilepsy

In brief

This is an open label prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure detection system for detecting Generalized Tonic-Clonic (GTC) Seizures.

Key facts

Study ID

NCT02752373

Run by

Brain Sentinel

People needed

5

Starts

2016-05-01

Expected to finish

2017-02-01

Last updated by the study team

2017-03-20

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 greater than 2 years of age
• Has an upper arm circumference which is adequate for proper fit of the EMG monitor (at least 16-51 cm)
• Be able to tolerate wearing the device on the upper arm
• 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
• At least 2 or more Emergency Department visits in the previous 12 months for seizure related care

You may not qualify if…

• The subject is homeless or in a home without a power supply.
• The subject is allergic to adhesives or any component of the electrode patch assembly.
• The subject self-reports that she is pregnant or planning to become pregnant while using the device.

Where it is running

• Nationwide Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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