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?

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

calibration study:
• Adults aged 18 years or older
• Normal intelligence;Patients with frontal lobe epilepsy:
• Patients aged 8 to18 years
• Clinical and electroencephalographic evidence of seizures originating from the frontal lobe. When EEG is not informative, we require the recording of more than one seizure with clinical evidence of seizures originating from the frontal lobe (Provini et al (1)).
• Non-symptomatic epilepsy;Healthy control group:
• Children aged 8 to 18 years
• Normal intelligence/following regular schools

Exclusion Criteria

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: These new techniques may reveal structural<br /><br>abnormalities that are related to FLE or cognitive impairment or refractoriness<br /><br>or all.<br /><br>So endpoints are the macro-structural, micro-structural and functional<br /><br>integrity, seizure history, IQ, and response to anti-epileptic drug treatment. </p><br>

Secondary Outcome Measures