XLTCS - Version number 1.0 dd 24-Jul-2019
Research type
Research Study
Full title
Accelerometer data collection in an Epilepsy Monitoring Unit (EMU)
IRAS ID
275625
Contact name
Femke Roelandt
Contact email
Sponsor organisation
LivaNova Belgium
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The XLTCS study is an international multicenter prospective data collection study to gather accelerometer data from subjects monitored in an Epilepsy Monitoring Unit (EMU) with concurrent video EEG. Subjects who have been admitted to an EMU for video EEG monitoring (independent of this study) who are expected to have at least one seizure with tonic-clonic convulsive movement, can be enrolled to this study. When participating in the study, real-time accelerometer data will be collected from the subject. An accelerometer is a tool that detects the speed and direction of the patient’s movements. It will not have any diagnostic or therapeutic application. Accelerometers are common in products like Fitbits, smartphones, and Apple Watches. The movement data will be collected by a tool called the “Accelerometer Live Streamer”, which we abbreviate as “XLS tool”. The subject will receive an XLS tool, which is a data collection tool that is placed on the subject’s upper left chest, using commercially available surface electrodes. If agreed by the subject, subject will also receive an XLS on the left wrist using a wrist band. The XLS will transmit real time accelerometer data via Bluetooth to a nearby laptop computer. Subjects will be followed during their stay in the EMU (with a minimum of 2 days and up to 10 days).
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0027
Date of REC Opinion
31 Mar 2020
REC opinion
Further Information Favourable Opinion