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

Withdrawn

• Conditions: Epilepsy, Tonic-Clonic

• Registration Number: NCT04282681
• Lead Sponsor: LivaNova

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 Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.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

• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-25
• Study Start: 2020-03-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-25
• Primary Completion: 2021-08-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Four (4) years of age or older.
2. Admitted to an Epilepsy Monitoring Unit for video EEG monitoring.
3. 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.
4. Capable of understanding and willing to comply with instructions and study procedures.
5. Subject or guardian must be willing and able to complete informed consent/assent.

Exclusion Criteria

1. Based on medical history, expected to have only non-epileptic events during the EMU stay as determined by the investigator.
2. Based on medical history, known to have only absence seizures.
3. Medical or psychiatric condition that in the investigator's judgment would prevent the subject's successful completion of the study.
4. Participants with known hypersensitivity or skin sensitivity conditions that will preclude attachment of the accelerometer.
5. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate accelerometer data and tonic-clonic seizure data	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.

Trial Locations

Locations (1)

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium