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

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    LivaNova
Send
Updated on 16 February 2024
See if I qualify

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 Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.

Details
Condition grand mal epilepsy
Age 4years - 99years
Treatment Accelerometer Live-Streaming Tool
Clinical Study IdentifierNCT04282681
SponsorLivaNova
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.