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

Epilepsy, Tonic-Clonic Clinical Trial

— XLTCS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04282681
• Other study ID #: LNE-800
• Status: Withdrawn
• Start date: March 16, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: August 2020
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 28, 2022
• Est. primary completion date: August 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Epilepsy, Tonic-Clonic

Intervention

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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate accelerometer data and tonic-clonic seizure data	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.	1.5 years