Epilepsy, Tonic-ClonicXLTCSNCT04282681
XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)
An observational study of Epilepsy, Tonic-Clonic, run by LivaNova at 1 site in Belgium.
Trial summary
The primary objective of this study is to collect accelerometer data from subjects monitored in an EMU with concurrent video EEG. Read more about this study
- Who is it for?
- Ages 4 to 99 years
- Conditions the study is for
- Epilepsy, Tonic-Clonic
- What is being tested?
- Accelerometer Live-Streaming Tool
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Mar 2020to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Epilepsy, Tonic-Clonic
- Being tested
- Accelerometer Live-Streaming Tool
- Medical subject headings
- Epilepsy, Tonic-Clonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerometer Live-Streaming ToolOther
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 is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start16 Mar 2020 (estimated)
- Primary completion28 Aug 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Why it stopped: Sponsor decision due to clinical strategy changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Tonic-ClonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- LivaNova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krisl Vonck, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282681
- Sponsor's protocol ID
- LNE-800
- Acronym
- XLTCS
- Status last verified
- Aug 2020
- First submitted
- 21 Feb 2020
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XLTCS - Accelerometer Data Collection in an Epilepsy Monitoring Unit (EMU)
- ClinicalTrials.gov ID
- NCT04282681
- Acronym / sponsor ID
- XLTCS / LNE-800
- Conditions
- Epilepsy, Tonic-Clonic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor decision due to clinical strategy changes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- LivaNovaIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2020 (estimated)
- Primary completion
- 28 Aug 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to collect accelerometer data from subjects monitored in an EMU with concurrent video EEG.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerometer Live-Streaming ToolThe 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. | Other | – |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krisl Vonck principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Tonic-Clonic, run by LivaNova at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate accelerometer data and tonic-clonic seizure data (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.