Epilepsies (ICD-10: G40), psychogenic non-epileptic seizures (ICD-10: F44–45, F98), and syncope/faint (ICD-10: R55) G40 F44 F45 F98 R55
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with a diagnosis of epilepsy or psychogenic nonepileptic seizures (PNES) Written informed consent provided by the patient or, where applicable, by the patient's parent(s), legal guardian, or legally authorized representative.
Exclusion criteria
Exclusion criteria: Age <7 years Patients unable to provide informed consent who do not have a legally authorized representative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Longitudinal changes in seizure frequency. Data will be collected at 3, 6, 12, 18, and 24 months after enrollment, followed by annual assessments for an additional three years. Data collection will be based on structured interviews and verified against the patients' medical records. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life in Epilepsy Inventory (QOLIE-10P); EuroQol (EQ-5D and EQ-VAS) for the assessment of generic health-related quality of life; WHOQOL-BREF for the assessment of overall quality of life; Beck Depression Inventory-II (BDI-II) for the assessment of depressive symptoms; Multidimensional Fatigue Inventory (MFI); Pittsburgh Sleep Quality Index (PSQI); 13-item Resilience Scale (RS-13); Berlin Social Support Scale (BSSS) for the assessment of perceived social support; and the Treatment Expectation Questionnaire (TEX-Q) for the assessment of treatment expectations. Side effects. Data will be collected at 3, 6, 12, 18, and 24 months after enrollment, followed by annual assessments for an additional three years. Data collection will be based on structured interviews and verified against the patients' medical records. | — |
Countries
Germany
Contacts
Universitätsklinikum des Saarlandes