Mainz Epilepsy Registry (MAINZ-EPIREG)

Study on Disease Course and Quality of Life in Patients With Epilepsy (Mainz Epilepsy Registry)

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Dissociative Seizures; Status Epilepticus
• Intervention / Treatment: Other: no interventions, only observation

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 Type: Observational
• Enrollment (Anticipated): 700

Contacts and Locations

• Study Contact: Name: Yaroslav Winter, MD, MSc; Phone Number: +496131172234; Email: yaroslav.winter@unimedizin-mainz.de

Study Locations

• Germany
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Recruiting
      • Mainz Comprehensive Epilepsy and Sleep Medicine Center
      • Contact: Winter Yaroslav, MD, MSc; Phone Number: +496131172234; Email: yaroslav.winter@unimedizin-mainz.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients treated in Mainz Comprehensive Epilepsy and Sleep Medicine Center

Description

Inclusion Criteria:

• Epileptic or psychogenic seizures

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monthly seizure frequency after 6 months	monthly seizure frequency at the follow-up after 6 months	6 months
European Quality of Life 5 dimensions Index (EQ 5D Index)	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)	6 months
monthly seizure frequency after 12 months	monthly seizure frequency at the follow-up after 12 months	12 months
European Quality of Life 5 dimensions Index (EQ 5D Index)	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)	12 months
Seizure freedom	percentage of patients without epileptic seizures	6 months
Seizure freedom	percentage of patients without epileptic seizures	12 months
interruption of status epilepticus	percentage of patients with interrupted status epilepticus	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resilience Scale 13	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	12 months
Resilience Scale 13	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	24 months
Multidimensional Fatigue Inventory	Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores	12 months
Multidimensional Fatigue Inventory	Multidimensional Fatigue Inventory: 20-item self-report instrument designed to measure fatigue. Measures range from 0-100, representing more severe fatigue at higher scores	24 months
Beck Depression Inventory II	Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)	12 months
Beck Depression Inventory II	Beck Depression Inventory II: higher scores correspond to more severe depression (range 0-63)	24 months
Berlin Social Support Scales (BSSS)	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	12 months
Berlin Social Support Scales (BSSS)	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	24 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)	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)	12 months
World Health Organization Quality of Life-BREF (WHOQOL-BREF)	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)	24 months
Pittsburgh Sleep Quality Index	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	12 months
Pittsburgh Sleep Quality Index	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	24 months

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Yaroslav Winter, MD, MSc, Mainz Comprehensive Epilepsy and Sleep Medicine Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Status Epilepticus
• Other Study ID Numbers: MAINZ-EPIREG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No