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

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON32704

Enrollment

Registered

2009-02-16

Start date

2009-04-24

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

Seizure/Epilepsy

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for the healthy adult group for the calibration study: 1. Adults aged 18 years or older 2. Normal intelligence;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 (Provini et al (1)). 3. Non-symptomatic epilepsy;Inclusion criteria for healthy control children: 1. Age of 8 to 12 years 2. Normal intelligence/following regular schools

Exclusion criteria

Exclusion criteria: Exclusion criteria for the healthy adult group for the calibration study: 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 5. The expressed wish not te be informed whenever structural abnormalities are found during imaging;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

Design outcomes

Primary

Measure	Time frame
Abnormalities that are related to FLE, cognitive impairment and/or refractoriness. Endpoints are the microstructural and functional integrity, seizure history, IQ, and response to anti-epileptic drug treatment.	—

Secondary

Measure	Time frame
Patient-related and epilepsy-related factors responsible for cognitive impairment and refractoriness.	—

Countries

Netherlands

Outcome results