Physiological and Biomechanical Data Collection Study in Epilepsy Subjects
The purpose of this study is to gather changes in physiological and biomechanical data during daily activity and sleep in epilepsy subjects.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Observational Study Collecting Physiological and Biomechanical Data in Ambulatory Subjects With Epilepsy|
- To gather changes in physiological and biomechanical data in epilepsy subjects [ Time Frame: 72 hours ] [ Designated as safety issue: No ]The E-32 study was designed to capture the subject's physiological and biomechanical data such as ECG data and rate, respiratory data and rate, and body orientation, motion and movement (accelerometry) during typical events such as walking, sitting, running and sleeping in order to help build a database of stereotypical human activity.
|Study Start Date:||November 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|ambulatory epilepsy subjects|
The purpose of this study is to gather changes in physiological and biomechanical data such as ECG, respiration, and accelerometry data during daily activity and sleep in pediatric and adult subjects with epilepsy. Subjects will use a device that enables monitoring of the human state in everyday, free-living environments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01485016
|United States, Texas|
|Clinical Trials of Texas, Inc.|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Douglas Denham, DO||Clinical Trials of Texas, Inc.|
|Study Director:||Bryan Olin, Ph.D||Cyberonics, Inc.|