XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU) (XLTCS)
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|ClinicalTrials.gov Identifier: NCT04282681|
Recruitment Status : Withdrawn (Sponsor decision due to clinical strategy changes)
First Posted : February 25, 2020
Last Update Posted : August 25, 2020
|Condition or disease||Intervention/treatment|
|Epilepsy, Tonic-Clonic||Other: Accelerometer Live-Streaming Tool|
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 Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)|
|Estimated Study Start Date :||March 16, 2020|
|Estimated Primary Completion Date :||August 28, 2021|
|Estimated Study Completion Date :||February 28, 2022|
- 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.
- Evaluate accelerometer data and tonic-clonic seizure data [ Time Frame: 1.5 years ]The study will evaluate accelerometer data and tonic-clonic seizure data that was collected during the patients' EMU admission. The sample size is not based on a statistical power calculation, thus no primary endpoint is defined in the clinical investigation plan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282681
|Universitair Ziekenhuis Gent|
|Principal Investigator:||Krisl Vonck||University Hospital, Ghent|