Ethical, social and legal aspects of patients with deep brain stimulatio
- Conditions
- G20G24Parkinson diseaseDystonia
- Registration Number
- DRKS00003221
- Lead Sponsor
- Medizinische Fakultät der Universität zu Kölnvertreten durch Herrn Univ.-Prof. Dr. Lars Timmermann
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 46
Inclusion criteria of patients
- patients with clinical diagnosis of idiopathic parkinson' disease or dystonia
- patients, who with obtained deep brain stimulation
- patients in the age between 30 and 80 with German as nature language
- patients with a mini mental status test with at least 25 points
- capability to agree and with a capibility to sign the written consent
Inclusion criteria of caregivers
- caregivers betweeen 30 and 80 with German as native language
- Caregivers with mini mental status test with at least 25 points
- Caregivers with the capability to agree and with a capibility to sign the written consent
Exclusion criteria of patients
- patients,who suffer on a different deterioation of cognition ( vascular disease, tumor, e.t.c.)
- patients, who suffer from an active psychiatric disorder
- patients, who take part in other studies, which could interfer with the exsitent study and whereby the partitipants could be endangered or especially be stressed or if the results of the study could be tampered
- patients, who do not agree to the interview of the caregivers
Exclusion criteria of caregivers
- caregivers who suffer parkinson's disease and dystonia themselfs
- caregivers, who suffer on a different deterioation of cognition ( vascular disease, tumor, e.t.c.)
- caregivers, who suffer from an active psychiatric disorder
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the comparison of the preoperative and 12 months postoperative measurement of subjective quality of life in patients and caregivers measured by parkinson's disease questionnaire 39
- Secondary Outcome Measures
Name Time Method Furthermore cognition, personality, social functioning, motor performance and mood were assessed: Beck depression inventory (BDI-2), Apathy evaluation scale (AES), Unified parkinson's disease reating scale part 3 (UPDRS-III), Social and Occupational Functioning Assessment Scale (SOFAS), brief test of attention (BTA), five-factor model of personality (NEO-FFI), semi-structured interview; time for exploration: pre-operatively, 1 week, 3 months and 12 months after implantation