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IMAGINE-Study (Imaging in Epilepsy) Onderzoek naar de oorzaak van geheugenproblemen en falen van medicamenteuze behandeling bij kinderen met frontaalkwab epilepsie.

IMAGINE-study (Imaging study in epilepsy) Is there a neuronal correlate for cognitive impairment and response to antiepileptic drugs in children with frontal lobe epilepsy?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28826
Enrollment
90
Registered
2009-04-07
Start date
2008-11-06
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frontal lobe epilepsy (FLE), i.e. epilepsy with a frontal epileptic focus, represents a substantial proportion of all partial epilepsies. The average age at onset of FLE is between 6 and 12 years. After the diagnosis FLE is made, the prognosis is still uncertain. Part of the children responds well to antiepileptic drug (AED) treatment, while others will become refractory and have frequent and disabling seizures. A second problem is that part of the children with FLE will suffer from cognitive im

Interventions

1. All eligible children diagnosed with FLE will get a structural brain MRI scan, as well as a DTI, resting state fMRI and task related fMRI scan. Neuropsychological assessment will only be repeated i
2. Children of the healthy control group (matched for age) will get a neuropsychological assessment. Additionally, a structural MRI scan, as well as a DTI, resting state fMRI and task related fMRI sca

Sponsors

Epilepsy Center Kempenhaeghe
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for children with FLE: 1. Age of 8 to12 years; 2. Clinical and electroencephalographic evidence of seizures originating from the frontal lobe. When EEG is not informative, the recording of more than one seizure with clinical evidence of seizures originating from the frontal lobe is required to make the diagnosis; 3. Non-symptomatic epilepsy. Inclusion criteria for healthy control children: 1. Children aged 8 to 12 years; 2. Normal intelligence/following regular schools.

Exclusion criteria

Exclusion criteria: Exclusion criteria for children with FLE: 1. Multiple seizure foci involving more than one lobe of the brain documented on previous EEG studies; 2. Frontal lobe seizures thought to be a result of spread to the frontal lobes; 3. MRI lesions on previous structural brain MRI- or CT-scans or symptomatic epilepsy (e.g. tumours, vascular abnormalities, congenital dysgenesia); 4. Full scale IQ<70 on the Wechsler Intelligence Scale for Children-Third Edition (Wechsler 1991); 5. Progressive neurological disorders; 6. Other diseases/ causes that may underlie cognitive impairment (i.e. psychiatric diseases); 7. Inability to speak/understand the Dutch language; 8. Cognitive deterioration directly after starting with AED, or treatment with Topiramate or Phenobarbital; 9. Vision less than +4.5D or – 4.5D; 10. Claustrophobia; 11. Metal implants or other contraindication for MRI; 12. Parents not willing to provide informed consent. Exclusion criteria for the healthy control children: 1. Medical history of head trauma or other diseases/ causes that may underlie cognitive impairment (i.e. psychiatric diseases); 2. Inability to speak/understand the Dutch language; 3. Vision less than +4.5D or – 4.5D; 4. Claustrophobia; 5. Metal implants or other contraindication for MRI; 6. Parents not willing to provide informed consent; 7. Parents who do not want to get informed whenever structural abnormalities are found during imaging.

Design outcomes

Primary

MeasureTime frame
Macrostructural, microstructural and functional MRI parameters, combined with seizure history, IQ, and response to anti-epileptic drug treatment. The endpoints for the fMRI tasks are activation levels of different brain areas and the correlation between the time signals between these activated brain areas. This will be analysed pixel by pixel with an automatized computer analysis (SPM software). Herewith, we obtain a list of activation levels and correlation coefficients for every brain region for every patient and every healthy control. Hereafter, these data can, for every task, be statistically compared between patients and healthy controls. This is a standardized and well applied way of data analysis. Endpoints therefore include the activated brain regions and the level of interaction between these regions. This will be processed in terms of: 1. Correlation between fMRI results and neuropsychological test results, and; 2. Differences between patients and healthy controls.

Secondary

MeasureTime frame
Patient characteristics and epilepsy-related factors which may be responsible for cognitive impairment and refractoriness.

Contacts

Public ContactH. Braakman
h.braakman@mumc.nl+31 ()043 3877056

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)