Mainz Epilepsy Registry

• Conditions: Dissociative Seizures; Status Epilepticus; Epilepsy

• Registration Number: NCT05267405
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

Prospective longitudinal observational registry study of all patients with epilepsy treated in the Mainz Comprehensive Epilepsy and Sleep Medicine Center with the focus on the course of the disease and quality of life.

Detailed Description

Clinical parameters of patients, such as onset of the disease, prior medication, disease severity, which are important for the data analysis also collected retrospectively before the initiation of the registry. Data on the quality of life is collected only prospectively.

Study Timeline

• Study Start: 2018-02-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-23
• Last Update Submitted: 2022-02-23
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Epileptic or psychogenic seizures

Exclusion Criteria

• age<18
• patients who cannot provide informed consent and don't have a legal guardian

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
monthly seizure frequency after 12 months	12 months	monthly seizure frequency at the follow-up after 12 months
monthly seizure frequency after 6 months	6 months	monthly seizure frequency at the follow-up after 6 months
European Quality of Life 5 dimensions Index (EQ 5D Index)	12 months	health-related quality of life measured by EQ5D-Index (European Quality of Life 5 dimensions), rating from 0 (worst possible state) to 1 (best possible state)
Seizure freedom	12 months	percentage of patients without epileptic seizures
interruption of status epilepticus	48 hours	percentage of patients with interrupted status epilepticus

Secondary Outcome Measures

Name	Time	Method
Berlin Social Support Scales (BSSS)	24 months	Berlin Social Support Scales (BSSS) is used to assess the amount of emotional, informational and instrumental support received by patients: Total scores ranged from 15 to 60, higher scores identify better support
World Health Organization Quality of Life-BREF (WHOQOL-BREF)	24 months	World Health Organization Quality of Life-BREF (WHOQOL-BREF), a scale to assess overall quality of life with a range 0-100 (higher scores correspond better quality of life)
Multidimensional Fatigue Inventory	24 months	Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores
Beck Depression Inventory II	24 months	Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)
Pittsburgh Sleep Quality Index	24 months	Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances, scoring between 0 and 21 with higher scores corresponding to worse sleep quality
Resilience Scale 13	24 months	Resilience Scale 13 (short version with 13 questions): 13-66 points correspond with low resilience, 67-72 with moderate and 73-91 with high resilience

Trial Locations

Locations (1)

Mainz Comprehensive Epilepsy and Sleep Medicine Center; 🇩🇪 Mainz, Rheinland-Pfalz, Germany