WithdrawnNCT04282681XLTCSUpdated Aug 25, 2020

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

An observational study in Epilepsy, Tonic-Clonic, sponsored by LivaNova. Withdrawn at 1 site in Belgium. Open to participants aged 4 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-08-25.

Study summary

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

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 Exit from the study occurs when the subject's stay in the EMU is completed or the subject is withdrawn or withdraws from the study.

Conditions studied

Epilepsy, Tonic-Clonic

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Epilepsy, Tonic-Clonic 23

In context

Epilepsy, Tonic-Clonic

23 studies on the registry are indexed under Epilepsy, Tonic-Clonic; 3 are open to participants now.

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Lead sponsor

LivaNova is the lead sponsor of 40 studies on the registry; 2 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 4 Years to 99 Years
Sexes eligible: 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 /assent.

Exclusion criteria

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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 0 participants (actual)
Patient registry: No

Interventions

OtherAccelerometer 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.

What researchers measure

Primary outcomes

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.
Time frame: 1.5 years

Study locations

1 site

Universitair Ziekenhuis Gent
Ghent, Belgium

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2020; primary completion for Aug 2021, 17 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 21, 2020
First posted: Feb 25, 2020
StartEst.: Mar 16, 2020
Primary completionEst.: Aug 28, 2021
CompletionEst.: Feb 28, 2022
Last update: Aug 25, 2020

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04282681
Lead sponsor: LivaNova
Responsible party: Sponsor
First posted: Feb 25, 2020
Start date: Mar 16, 2020 (estimated)
Primary completion: Aug 28, 2021 (estimated)
Completion: Feb 28, 2022 (estimated)
Last update: Aug 25, 2020

Study contacts

Krisl Vonck

principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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