G35.9
Conditions
Interventions
Group 1: Patients with multiple sclerosis
Sponsors
Medizinische Fakultät der TU Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Confirmed diagnosis of multiple sclerosis according to the 2017 McDonald criteria in PmMS patients currently undergoing treatment at the MS Center • PmMS patients > 18 years of age • Written consent to participate in the observational study • Availability of the required routine clinical data in the digital patient record • Capacity to consent and written consent to participate in the study following comprehensive informed consent
Exclusion criteria
Exclusion criteria: • Implanted electronic devices (e.g., pacemakers, defibrillators) • Portable medical devices (including ECG machines, artificial lungs, etc.) • PmMS patients for whom standardized bioelectrical impedance analysis cannot be performed due to an inability to stand • Current pregnancy • Lack of informed consent • Severe fluid retention, primarily in the legs, attributable to other comorbid conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the registry is the structured collection of clinical, metabolic, and patient-reported routine data from PmMS. Through systematic data collection, the registry aims to investigate potential associations between energy metabolism, the presence of metabolic syndrome, and disease-related and care-related characteristics. The registry serves both to provide a descriptive overview of the registry population and to conduct exploratory analyses of potential associations between metabolic parameters and clinical course characteristics. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Identification and exploratory analysis of potential associations between metabolic syndrome and clinical MS parameters, particularly hospitalizations and the progression of disability ? Descriptive presentation of selected comorbidities and concomitant medications as well as their potential association with metabolic parameters in PmMS ? Description of the prevalence and distribution of metabolic risk factors in PmMS in routine clinical practice. ? Collection of patient-reported outcomes, including patient satisfaction, health-related quality of life, and fatigue, using standardized and validated questionnaires. ? Derivation of evidence-based recommendations for individualized, interdisciplinary care of PmMS, taking into account neurological and metabolic aspects based on the collected registry data. | — |
Countries
Germany
Contacts
Public ContactTjalf Ziemssen
MS-Zentrum am Zentrum für klinische Neurowissenschaften, Universitätsklinikum Carl-Gustav-Carus Dresden
Outcome results
None listed