G20
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients suffering from a clinical diagnosis of iPD according to the recent clinical diagnostic criteria (MDS criteria) iPD-stages of I – IV according to the Hoehn & Yahr scale (in the OFF state, i.e., without medication) Patients aged between between 30 and 100 years Patients with the ability to provide informed consent. In cases where participants lose their capacity to consent at follow-up visits (e.g., due to dementia, etc.), this participant will only be allowed to continue if a legal representative (proxy, guardian) provides informed consent to further par- ticipation on behalf of the participant. In this case, the legal representatives will be provided with a separate consent form
Exclusion criteria
Exclusion criteria: Patients suffering from a clinical diagnosis of atypical Parkin- son’s syndrome in a first instance. Patients enrolled who were later characterized as atypical Parkinson syndroms will not be excluded. iPD-stages of V according to the Hoehn & Yahr scale (in the OFF stage, i.e. without medication) The use of magnetic fields in the MRI examination excludes the participation of persons who have electrical devices (e.g., cardiac pacemakers, medication pumps, etc.) or metal parts (e.g., screws after bone fracture) in or on their bodies Women who are pregnant will not receive MRI. Subjects who do not want to be informed about possible incidental findings are also not allowed to participate in the imaging part of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parkinson's disease patients holistic quality of life - measurements take place every half year in the form of a questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom severity, affective symptoms, cognitive decline, sleep quality at six-monthly assessments. In addition, structural changes in the brain will be assessed by cranial imaging and metabolic changes will be assessed in blood, saliva, urine and stool samples. These changes are recorded through annual presentations and sample collection or measurements. In addition, quality of life, coping, resilience and family burden are assessed. Measurements are also taken every six months using questionnaires. | — |
Countries
Germany
Contacts
Universitätsklinikum Marburg