NCT04282681

XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 4 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to collect accelerometer data from subjects monitored in an EMU with concurrent video EEG.

Detailed description

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 Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.

Conditions

• Epilepsy, Tonic-Clonic

Interventions

Type	Name	Description
OTHER	Accelerometer Live-Streaming Tool	The only 'intervention' that will take place is the placement of the XLS tool(s) on the upper left chest and/or left wrist of the patient.

Timeline

• Start date: 2020-03-16
• Primary completion: 2021-08-28
• Completion: 2022-02-28
• First posted: 2020-02-25
• Last updated: 2020-08-25

Locations

1 site across 1 country: Belgium