'Epilepsy' 'Seizure disorders' 'Convulsions' Epilepsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: We will include patients >=12 years old with a first unprovoked seizure with a non-epileptiform baseline EEG. In order to be eligible to participate in this study, a subject must meet all of the following criteria: • The patient was at least 12 years old at the time of the seizure. • The treating physician should consider that the patient had an epileptic seizure (not just a syncope). • Epilepsy is considered as a potential diagnosis by the treating physician(the repeated EEG should be requested due to an ongoing suspicion of epilepsy although the bEEG showed no epileptiform abnormalities, not just to reassure the patient).
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - The seizure was most likely acute symptomatic or provoked by drugs, alcohol withdrawal, or extensive sleep deprivation (at least 24-hours awake). - Initial presentation with status epilepticus. - Explanatory structural abnormality on imaging prior to inclusion, based on which epilepsy diagnosis can be established. - Explanatory syndrome or genetic mutation based on which epilepsy diagnosis can be established. - Prior epilepsy diagnosis. - Known or suspected neurodegenerative disease.* - Moderate to profound intellectual disability (IQ <50).* - Daily use of antiseizure medication for any reason (e.g. migraines/psychiatric indication/chronic pain). NB: this includes daily use of benzodiazepines. - Not able or willing to provide (written) informed consent. - Not able or willing to answer questionnaires in Dutch or English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are repeated EEG diagnostic sensitivity (percentage of patients with epileptiform abnormalities on repeated EEG out of all patients with a certain epilepsy diagnosis after 2-year follow-up) and EEG-specific patient burden. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include overall diagnostic accuracy, sleep deprivation-associated seizure risk (measured by comparing the frequencies of recurrent seizures within 24 hours after the EEG of the two EEG strategies), cumulative incidence of seizure recurrence, patient burden in terms of quality of life and indicators for depression/anxiety, physician working diagnosis and probability estimate of epilepsy likelihood. | — |
Countries
Netherlands
Contacts
Universitair Medisch Centrum Utrecht