Absence EpilepsyLEESNCT02954107
Longitudinal Early Epilepsy Study
An observational study of Absence Epilepsy and Epilepsy, Absence, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
This longitudinal study will focus on the cognitive and brain development of children with absence epilepsy. In addition, the investigators aim to identify prognostic factors for cognitive deterioration and/or poor seizure control in these children. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Absence Epilepsy, Epilepsy, Absence
- What is being tested?
- MRI, 24h-EEG + video and Neuropsychological tests
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2016to Jan 2020
- How long will I take part?
- 2 Years
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1. Children aged 6-12 years of age primarily presenting with episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years. With an EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG. 2. Overall healthy children aged 6-12 years of age following a regular school without major problems.
Who may be able to join
- Primarily presented with daily occurring episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years.
- An EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG(58).
- Early absence epilepsy , defined as a confirmed diagnosis or seizures within 2 years.
- Aged 6-12 years
- Permitted accompanying factors:
- A few generalized tonic-clonic seizures (assessed individually according to International League Against Epilepsy [ILAE] statements;
- Mild myoclonic eye(lid) movements
- Co-morbidities: Attention deficiency/concentration disorders, autism, dyslexia and anxiety. These do not form exclusion criteria as this is frequently seen in children with absence seizures and it might be uncertain if the co-morbidity is a manifestation of the absence epilepsy.
Who cannot join
- A potential subject (both for the control and patient group) who meets any of the following criteria will be excluded from participation in this study:
- A diagnosis according to ILAE criteria of the following epilepsy syndromes: Juvenile Absence Epilepsy; Eyelid myoclonia with absences; Dravet syndrome; Epilepsy with myoclonic-atonic seizures; Epilepsy with Myoclonic Absences; Lennox-Gastaut syndrome; Frontal Lobe Epilepsy or other focal epilepsy.
- A confirmed diagnosis of epilepsy/seizures for more than 2 years (59).
- Recent hospitalizations in the last months or a history which might limit participation in or completion of the study protocol.
- Behavioural characteristics which might hamper the gathering of useful MRI data.
- Intellectual disability or other diseases/causes that may underlie cognitive impairment (i.e. neurodegenerative diseases).
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- History of major head trauma or head/brain surgery.
- MRI lesions on (previous) structural brain MRI- or CT-scans or symptomatic epilepsies (e.g. epilepsy related to tumours, vascular abnormalities, congenital dysgenesia).
- MRI contra-indications: claustrophobia, anxiety for an MRI scan, or presence of metallic objects (e.g. prostheses, pacemakers, metal clips on blood vessels, metal parts in the eye). Dental braces are no exclusion criterion for absence patients.
- Regularly using drugs of abuse (asked during screening session).
- Parents or participants (aged≥12 years) not willing to provide informed consent.
- Parents or participants (aged≥12 years) who do not want to get informed whenever structural abnormalities are found during imaging.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Recruiting
Kempenhaeghe
Heeze, Limburg, 5591 VE
Mariette HJ Debeij-van Hall, MD, PHD, +31 (0)40 227 97 77, debeij-vanhallm@kempenhaeghe.nl
- Recruiting
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ
Eric LA Fonseca Wald, MD, +31 (0)43 387 65 84, eric.fonsecawald@mumc.nl
Sylvia Klinkenberg, MD, PHD, +31 (0)43 387 70 54, s.klinkenberg@mumc.nl
About this study
This longitudinal study will focus on the cognitive and brain development of children with absence epilepsy. In addition, the investigators aim to identify prognostic factors for cognitive deterioration and/or poor seizure control in these children.
Read the detailed description
The aim is to study the cognitive and brain development of children with absence epilepsy. In addition, this study aims to identify prognostic factors for cognitive deterioration and/or poor seizure control.
Objective:
- To study the development of cognition in children with absence epilepsy and the functional brain organization over time.
- To find prognostic factors in terms of clinical, 24h-video-EEG or/and MRI characteristics for cognitive deterioration and/or poor seizure control in patients with absence epilepsy.
Study design:
2 year prospective longitudinal, controlled, comparative, clinical, follow up.
Study population:
60 children with recently diagnosed (<2 years) absence epilepsy, aged 6 to 12 years. In addition, this study includes a control group of 15 age and gender matched healthy volunteers.
Main study parameters/endpoints:
Endpoints are the development of clinical parameters (semiology, 24h-video-EEG and seizure control), neuropsychological/behavioural outcomes, structural/functional MRI parameters, and educational performance.
- Conditions
- Absence Epilepsy, Epilepsy, Absence
- Being tested
- MRI, 24h-EEG + video, Neuropsychological tests
- Medical subject headings
- Epilepsy, Absence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
24h-EEG + videoOther
Neuropsychological testsOther
| Study group | Role | What they receive |
|---|---|---|
| Absence epilepsy | Children aged 6-12 years of age primarily presenting with episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years. With an EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG. Receives: Other: MRI; Other: 24h-EEG + video; Other: Neuropsychological tests | |
| Controls | Overall healthy children aged 6-12 years of age following a regular school without major problems. Receives: Other: MRI; Other: Neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of multimodal MRI parameters on brain connectivity
Measured: Baseline; first year; second year
Change of cognition measured by a battery of neuropsychological tests
Measured: Baseline; first year; second year
Time in months since start of medication till seizure control is attained, as assessed by anamnesis and a confirmatory routine-EEG.
Measured: Within 2 years
Secondary outcomes (3)
Age in months at which seizures began (age of onset) assessed by interview at the baseline measurment
Measured: Baseline
Seizure semiology assessed by anamnesis and video-EEG
Seizure semiology will be re-assessed at the different time points
Measured: Baseline; first year; second year
Epileptiform activity assessed by a 24h-EEG
Epileptiform acitivty will be re-assessed at the different time points
Measured: Baseline; first year; second year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absence EpilepsyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Epilepsiecentrum Kempenhaeghe
- Responsible party
- Sponsor
- Investigators
- Johan SH Vles, MD, PHD, Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954107
- Sponsor's protocol ID
- NL55455.068.15
- Other IDs
- 152055
- Acronym
- LEES
- Status last verified
- Nov 2018
- First submitted
- 26 Sep 2016
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Early Epilepsy Study
- ClinicalTrials.gov ID
- NCT02954107
- Acronym / sponsor ID
- LEES / NL55455.068.15
- Conditions
- Absence Epilepsy, Epilepsy, Absence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Epilepsiecentrum Kempenhaeghe
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 3 Nov 2016 (estimated)
- 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.
This longitudinal study will focus on the cognitive and brain development of children with absence epilepsy. In addition, the investigators aim to identify prognostic factors for cognitive deterioration and/or poor seizure control in these children.
Detailed description
The aim is to study the cognitive and brain development of children with absence epilepsy. In addition, this study aims to identify prognostic factors for cognitive deterioration and/or poor seizure control.
Objective:
- To study the development of cognition in children with absence epilepsy and the functional brain organization over time.
- To find prognostic factors in terms of clinical, 24h-video-EEG or/and MRI characteristics for cognitive deterioration and/or poor seizure control in patients with absence epilepsy.
Study design:
2 year prospective longitudinal, controlled, comparative, clinical, follow up.
Study population:
60 children with recently diagnosed (<2 years) absence epilepsy, aged 6 to 12 years. In addition, this study includes a control group of 15 age and gender matched healthy volunteers.
Main study parameters/endpoints:
Endpoints are the development of clinical parameters (semiology, 24h-video-EEG and seizure control), neuropsychological/behavioural outcomes, structural/functional MRI parameters, and educational performance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absence epilepsy | – | Other: MRI, Other: 24h-EEG + video, Other: Neuropsychological testsChildren aged 6-12 years of age primarily presenting with episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years. With an EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG. |
| Controls | – | Other: MRI, Other: Neuropsychological testsOverall healthy children aged 6-12 years of age following a regular school without major problems. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1. Children aged 6-12 years of age primarily presenting with episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years. With an EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG. 2. Overall healthy children aged 6-12 years of age following a regular school without major problems.
Key inclusion criteria (8 listed)
- Primarily presented with daily occurring episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years.
- An EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG(58).
- Early absence epilepsy , defined as a confirmed diagnosis or seizures within 2 years.
- Aged 6-12 years
- Permitted accompanying factors:
Key exclusion criteria (12 listed)
- A potential subject (both for the control and patient group) who meets any of the following criteria will be excluded from participation in this study:
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 |
|---|---|---|
| MRI | Other | Absence epilepsy, Controls |
| 24h-EEG + video | Other | Absence epilepsy |
| Neuropsychological tests | Other | Absence epilepsy, Controls |
Primary outcome
Change of multimodal MRI parameters on brain connectivity
Time frame: Baseline; first year; second year
Change of cognition measured by a battery of neuropsychological tests
Time frame: Baseline; first year; second year
Time in months since start of medication till seizure control is attained, as assessed by anamnesis and a confirmatory routine-EEG.
Time frame: Within 2 years
3 secondary outcomes
Age in months at which seizures began (age of onset) assessed by interview at the baseline measurment
Time frame: Baseline
Seizure semiology assessed by anamnesis and video-EEG
Time frame: Baseline; first year; second year
Epileptiform activity assessed by a 24h-EEG
Time frame: Baseline; first year; second year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Johan SH Vles, MD, PHD study director
Maastricht University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Absence Epilepsy and Epilepsy, Absence, run by Maastricht University Medical Center at 2 sites in Netherlands.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric LA Fonseca Wald, MD (+31 (0)43 387 65 84, LEES.studie.kinderneurologie@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of multimodal MRI parameters on brain connectivity (time frame: Baseline; first year; second year). The study lists 3 primary outcomes in all. 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 19 Nov 2018.