Seizure G40
Conditions
Interventions
Group 1: In-depth diagnostic approach (intervention group):
• Admission to a epilepsy monitoring unit with 24h continuous video-EEG monitoring
including sleep monitoring with 25 scalp electrodes.
• Em
Sponsors
Insel Gruppe
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: - first unprovoked focal or generalised epileptic seizure within the last 24 hours after seizure onset - age =16 years of age - signed informed consent either by the participants themselves or by their legal guardian. In cases in which the participant is not able to provide signed informed consent herself/himself e.g. due to altered level of consciousness or confusional state written informed consent can also be provided by a next of kin with legal representation rights to approve or deny medical treatment in the name of the patient according to local and federal laws and regulations or by an independent physician who deems the participation in the best interest of the participant. The person concerned will be duly informed about the research project as soon as this becomes possible. He or she may subsequently give or withhold consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria: - previously established diagnosis of epilepsy according to current guidelines of the International League Against Epilepsy. - previously established diagnosis of an unprovoked seizure or acute symptomatic seizure, in which case the current seizure represents a seizure recurrence and establishes the diagnosis of epilepsy. Of note, undiagnosed focal aware seizures (i.e. epileptic auras) reported by the patient are not an exclusion criterion. - current diagnosis of an acute symptomatic or provoked seizure defined according to current recommendation of the International League Against Epilepsy (i.e. close temporal relationship with an acute central nervous system insult, which may be metabolic, toxic, structural, infectious, or due to inflammation including alcohol and/or illicit drugs). - clinical indication for prolonged EEG monitoring (e.g. due to status epilepticus) - blood alcohol exceeding the legal limit for driving (i.e. >0.5 ‰) - current use of illicit drugs and/or positive urine drug test (excluding therapeutic drugs) - contraindication for non-contrast enhanced MRI (e.g. any kind of implanted cardiac pacemaker or stimulator, non-MRI-compatible metallic artefacts, severe claustrophobia) - inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. - Patient incapable of judgement who is showing symptoms indicating that she or he is unwilling to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in this diagnostic trial is the delay to a correct initial diagnosis, which can be one of the following: 1. Epilepsy presenting with a first unprovoked seizure 2. First unprovoked seizure without diagnosed epilepsy 3. Provoked seizure, not diagnosed at enrolment 4. Non-epileptic event (i.e. ‘seizure mimics’, e.g. syncope, transient ischemic attack, migraine with aura, transient global amnesia, parasomnia, psychogenic non-epileptic seizure, intoxication, other likely explanation or unclear cause). The time window for the initial diagnosis is set at 9 days after the index event. The correctness of the initial diagnosis will be evaluated as the accuracy at the time of diagnosis against the ground-truth diagnosis after a 24 months follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The degree of certainty in the initial diagnosis • The delay in initiating an anti-seizure treatment • The seizure free survival • The healthcare burden: The cost of care over 24 months, the number of ambulatory or hospital visits. • Psychological burden and differences in quality of life between the intervention and the control cohort assessed during an outpatient visit at 3-6 months through: quality of life assessment using Quality of life in epilepsy-31 inventory (QOLIE-31), semi-structured interview with quantitative assessment. • Screened versus enrolled population to ensure the lack of bias due to enrolment times. | — |
Countries
Switzerland
Contacts
Public ContactMaxime Baud
Universitätsspital Bern Inselspital, Universitätsklinik für Neurologie
Outcome results
None listed