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| ID | Type | Description | Link |
|---|---|---|---|
| 152055 | Other Identifier | Maastricht University Medical Centre+ |
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| Name | Class |
|---|---|
| Epilepsiecentrum Kempenhaeghe | INDUSTRY |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Controls | Overall healthy children aged 6-12 years of age following a regular school without major problems. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Other |
| ||
| 24h-EEG + video |
| Measure | Description | Time Frame |
|---|---|---|
| Change of multimodal MRI parameters on brain connectivity | Baseline; first year; second year | |
| Change of cognition measured by a battery of neuropsychological tests | 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. | Within 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Age in months at which seizures began (age of onset) assessed by interview at the baseline measurment | Baseline | |
| Seizure semiology assessed by anamnesis and video-EEG | Seizure semiology will be re-assessed at the different time points |
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Inclusion Criteria:
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:
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric LA Fonseca Wald, MD | Contact | +31 (0)43 387 65 84 | LEES.studie.kinderneurologie@mumc.nl | |
| Sylvia Klinkenberg, MD, PHD | Contact | +31 (0)43 387 70 54 | s.klinkenberg@mumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Johan SH Vles, MD, PHD | Maastricht University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kempenhaeghe | Recruiting | Heeze | Limburg | 5591 VE | Netherlands |
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| ID | Term |
|---|---|
| D004832 | Epilepsy, Absence |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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| Neuropsychological tests | Other |
|
| Baseline; first year; second year |
| Epileptiform activity assessed by a 24h-EEG | Epileptiform acitivty will be re-assessed at the different time points | Baseline; first year; second year |
| Maastricht University Medical Center | Recruiting | Maastricht | Limburg | 6202 AZ | Netherlands |
|
| D009422 |
| Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |