Mainz Epilepsy Registry

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Status Epilepticus, Epilepsy, Dissociative Seizures

Intervention / Treatment
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* Other: no interventions, only observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epileptic or psychogenic seizures Exclusion Criteria: age<18 patients who cannot provide informed consent and don't have a legal guardian

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no interventions, only observation|no interventions, only observation|

What is the study measuring?
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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 |