G20
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients with idiopathic Parkinson's syndrome according to UK Brain Bank criteria Further inclusion criteria: - Written informed consent based on Good Clinical Practice (GCP) and local legislation - Age of majority - Reconnaissance capability - Legal capacity
Exclusion criteria
Exclusion criteria: - Lack of agreement with protocol - Drugs or alcohol dependency within 6 months before signing the consent form - Stereotactic surgery in the history - Electroconvulsive therapy in the last 180 days before screening - Severe dementia based on a score of <10 in the Mini Mental State Examination (MMSE) - Depression with suicidal thoughts (previous episodes of severe depression are not a criterion for exclusion) - Illiteracy or insufficient language skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the effectiveness of sensor-based parameters for the evaluation of treatment success in motor, gait and executive dysfunctions of Parkinson's patients. The questionnaires as well as the sensor measurements are collected at the beginning of the therapy, time T1, and at the end of the therapy, time T2. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Determination of output values of sensor-based parameters for the evaluation of motor, gait and executive function disorders in Parkinson's patients - Determination of the reproducibility of sensor-based parameters for motor, gait and executive dysfunctions in patients, which is necessary for the calculation of the minimal detectable change and thus for the detection of an effective treatment - Exploratory comparison of the above parameters / changes in parameters during the course of treatment, with clinical and quantitative imaging parameters. The questionnaires as well as the sensor measurements are collected at the beginning of the therapy, time T1, and at the end of the therapy, time T2. | — |
Countries
Germany
Contacts
St. Josef-Hospital