Epilepsy, Tonic-Clonic Clinical Trial
Official title:
XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)
The primary objective of this study is to collect accelerometer data from subjects monitored in an EMU with concurrent video EEG.
XLTCS (LNE-800) is an international multicenter prospective data collection study to gather
accelerometer data. The population under the study comprises patients monitored in an
Epilepsy Monitoring Unit (EMU) with concurrent video EEG and who are expected to have at
least one seizure with tonic-clonic convulsive movement.
A maximum of one hundred and fifty (150) patients will be enrolled and will wear an
accelerometer, and up to 6 sites may participate in this study. The total enrollment period
will take approximately 2 years.
Once the accelerometer was adhered to the subject, subjects will be followed for a minimum of
2 days and a maximum of 10 days.
Subject participation will run concurrently with the EMU admission. Exit from the study
occurs when the subject's stay in the EMU is completed or the subject is withdrawn or
withdraws from the study.
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