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Registry Study on the Multidimensional Assessment of Disease Course and Quality of Life in Patients with Epilepsy and Psychogenic Nonepileptic Seizures in Southwestern Germany

Registry Study on the Multidimensional Assessment of Disease Course and Quality of Life in Patients with Epilepsy and Psychogenic Nonepileptic Seizures in Southwestern Germany - EPISWED-REG

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00041100
Enrollment
5000
Registered
2026-07-27
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Epilepsies (ICD-10: G40), psychogenic non-epileptic seizures (ICD-10: F44–45, F98), and syncope/faint (ICD-10: R55) G40 F44 F45 F98 R55

Interventions

Group 1: This registry study is designed to describe the longitudinal clinical course of patients with epilepsy and psychogenic nonepileptic seizures (PNES). A multidimensional assessment with follow-

Sponsors

Universitätsklinikum des Saarlandes
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactYaroslav Winter

Universitätsklinikum des Saarlandes

yaroslav.winter@uks.eu+4968411614107

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026