G20
Conditions
Interventions
Group 1: PD patients take safinamide after DBS surgery (50mg in week 1, 100mg from week 2 on)
Group 2: PD patients do not take safinamide after DBS
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Patients with idiopathic Parkinson´s disease Hoehn & Yahr 2-4 2) Eligible candidates for STN-DBS therapy according to CAPSIT protocol criterias[12] 3) Age: 35-80 years 4) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with atypical Parkinsonism 2) Non-existent informed consent or limited patient compliance 3) Age 80 years 4) Impaired physical or psychic condition (severe heart condition with shortened 5) Gait distance, inadequately controlled hallucinations, acute psychosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life (Parkinson's Disease Questionnaire (PDQ-39) (Postoperative-Preoperative difference), baseline: preoperative; Follow-up: 3-months after Deep Brain Stimulation surgery in the subthalamic nucleus (STN-DBS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Non-motor symptoms such as apathy (LARS), sleep (PDSS), fatigue (MFIS), impulse control disorder (QUIP-RS), depression (BDI-II). Gait and balance (Ziegler Freezing of Gait Score, Berg Balance Score, Giladi FOG Questionnaire, 14-meter Walk Test), levodopa equivalent daily dose (LEDD), activities of daily living (Schwab & England Score), cognition (MoCA, MDRS). | — |
Countries
Germany
Contacts
Public ContactMonika Pötter-Nerger
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed