G20
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - written consent form based on Good Clinical Practice (GCP) and the local legislation - male and female patients with idiopathic Parkinson's Disease based on the criteria of the Parkinson's Disease Society Brain Bank - patients have to be willing and able to participate in the psychometric and motor examinations
Exclusion criteria
Exclusion criteria: - atypical Parkinson's Syndromes (medicinal, metabolic, inflammatory or degenerative) - stereotactic surgery in the medical history - electroconvulsive therapy in the past 180 days before the screening - pregnancy, planned pregnancy or breastfeeding - missing consent with the protocol - severe dementia on the basis of a score 40 g/day; women >30 g/day) - illiteracy or insufficient language skills to complete the questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of clinical condition assessed by the Clinical Global Impression Scale - Global Change (CGI-C) rated by doctor and patient immediately at the end of treatment and at a 6 week follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the following secondary outcomes at start and end of the therapy, as well as 6 weeks after the end of the therapy: - score of UPDRS-III (motor examination): Unified Parkinson’s Disease Rating Scale - EQ-5D-5L (quality of life in general) - PDQ-39 (quality of life in PD patients) - Record of expectations of patients and caregivers towards the 'Parkinson's complex therapy', evaluation of their satisfaction - further aspects | — |
Countries
Germany
Contacts
St. Josef-HospitalKlinik für Neurologie