Social maladaptation after subthalamic deep brain stimulation for Parkinson's Disease

• Conditions: G20; Parkinson disease

• Registration Number: DRKS00010876
• Lead Sponsor: Medizinische Psychologie: Neuropsychologie und Gender Studies, Uniklinik Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-11
• Study Completion: 2020-08-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Inclusion criteria patients with Parkinson's Disease with STN-DBS
• Clinical diagnosis of idiopathic PD (UK Brain Bank criteria, Hughes et al., 1992)
• Planned STN-DBS surgery
• Patients up to 80 years of age
• Minimum MMSE score = 25
• Able to give written informed consent
• German as native language

Inclusion criteria patients with Parkinson's Disease without STN-DBS
• Clinical diagnosis of idiopathic PD (UK Brain Bank criteria, Hughes et al., 1992)
• Patients up to 80 years of age
• Minimum MMSE score = 25
• Able to give written informed consent
• German as native language

Inclusion criteria healthy controls
• Individuals up to 80 years of age
• Minimum MMSE score = 25
• Able to give written informed consent
• German as native language

Exclusion Criteria

Exclusion criteria patients:
• Any other neurological diseases besides PD (e.g., stroke, TBI, epilepsy)
• Psychiatric diseases (e.g. schizophrenia, bipolar disorder)
• Drug/medication addiction and/or alcohol addiction
• Patients at a late stage of the disease (stage 4 H &Y)
• Signs of dementia (MMSE < 25)
• Patients who are under medication for another disease indication with possible effects on the CNS

Exclusion criteria healthy controls:
• Indviduals with a clinical diagnosis of idiopathic PD
• Any other neurological or psychiatric disease
• Individuals who are cognitively impaired (e.g., vascular incidents, dementia, etc.)
• 1 week before the testing: intake of substances that impact on the CNS

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Social maladaption, measured by: self estimation and risk-seeking behavior in a social context, Reading the Mind in the Eyes Test, Ultimatum Game, Emotional competence questionnaire, NEO-FFI, DASS, Mild Behavioral Checklist; conduct of all tests and questionnaires at all time points of measurement (pre-surgery, 3-months post-surgery and 12-months post-surgery)

Secondary Outcome Measures

Name	Time	Method
General cognitive state:<br>Mini Mental State Examination, PANDA, Dementia Rating Scale (Mattis)<br>executive functions:<br>Trail Making Test A/B, verbal fluency, modified Wisconsin Card Sortng Test, BADS (key search test), Stroop test, LPS-4<br>memory:<br>CERAD subtest (word list immediate & delayed recall)<br>attention:<br>Brief Test of Attention<br>visuo-constructive abilities:<br>CERAD subtest (figure copying)<br>Psychiatric symptoms:<br>Beck-Depression Inventory, mania self-evaluation scale, apathy evaluation scale, QUIP-RS<br>quality of life:<br>PDQ-39<br>social desirability:<br>SES; conduct of all tests and questionnaires at all time points of measurement (pre-surgery, 3-months post-surgery and 12-months post-surgery)