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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Recruitment Status : Withdrawn (Sponsor decision due to clinical strategy changes)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
Sponsor:
Information provided by (Responsible Party):
LivaNova

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

Condition or disease Intervention/treatment
Epilepsy, Tonic-Clonic Other: Accelerometer Live-Streaming Tool

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 Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Sponsors and Collaborators
LivaNova
Investigators
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Principal Investigator: Krisl Vonck University Hospital, Ghent
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Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT04282681    
Other Study ID Numbers: LNE-800
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Generalized
Epilepsy, Tonic-Clonic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases