Status:
WITHDRAWN
XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)
Lead Sponsor:
LivaNova
Conditions:
Epilepsy, Tonic-Clonic
Eligibility:
All Genders
4-99 years
Brief 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 Un...
Eligibility Criteria
Inclusion
- Four (4) years of age or older.
- Admitted to an Epilepsy Monitoring Unit for video EEG monitoring.
- Based on medical history, expected to have at least one seizure with tonic-clonic convulsive movement during the EMU stay as determined by the investigator.
- Capable of understanding and willing to comply with instructions and study procedures.
- Subject or guardian must be willing and able to complete informed consent/assent.
Exclusion
- Based on medical history, expected to have only non-epileptic events during the EMU stay as determined by the investigator.
- Based on medical history, known to have only absence seizures.
- Medical or psychiatric condition that in the investigator's judgment would prevent the subject's successful completion of the study.
- Participants with known hypersensitivity or skin sensitivity conditions that will preclude attachment of the accelerometer.
- Participants who are also taking part in another clinical trial that could confound the results of the study; these patients can be included into the study only if LivaNova has provided written approval.
Key Trial Info
Start Date :
March 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04282681
Start Date
March 16 2020
End Date
February 28 2022
Last Update
August 25 2020
Active Locations (1)
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1
Universitair Ziekenhuis Gent
Ghent, Belgium