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

August 24, 2020 updated by: LivaNova
The primary objective of this study is to collect accelerometer data from subjects monitored in an EMU with concurrent video EEG.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.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

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • Universitair Ziekenhuis Gent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 99 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been admitted to an EMU for video EEG monitoring (independent of this study) who are expected to have at least one seizure with tonic-clonic convulsive movement.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Investigators

  • Principal Investigator: Krisl Vonck, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 16, 2020

Primary Completion (ANTICIPATED)

August 28, 2021

Study Completion (ANTICIPATED)

February 28, 2022

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (ACTUAL)

February 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNE-800

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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