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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?

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? - IMAGINE-Study (Imaging study in epilepsy)

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32514
Enrollment
130
Registered
2008-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

epilepsy seizure

Interventions

None listed

Sponsors

Epilepsie Centrum Kempenhaeghe
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

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: 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Patient-related and epilepsy-related factors responsible for cognitive deterioration and refractoriness

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)