An observational study in Parkinson Disease, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational
The goal of this observational study is to evaluate the long-term effect of DBS-STN on cognitive and behavioral outcomes in Parkinson's disease (PD) patients.
PD patients will be assessed over time using tests, questionnaires and standardized clinical scales. An initial assessment (T0) and annual follow-up assessments will be carried out for 5 years.
Researchers will compare data collected from patients with DBS versus patients with best medical therapy.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 52 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with diagnosis of Parkinson's disease
Exclusion Criteria:
Patients with Parkinson's disease treated with DBS of the subthalamic nucleus
Diagnostic Test: Clinical examinations and clinical scales administration
Patients with Parkinson's disease not treated with DBS
Diagnostic Test: Clinical examinations and clinical scales administration
Psychometric assessment of cognitive and behavioral outcomes
Long-term characterization of DBS-STN on cognitive outcomes
Cognitive impairment change from baseline until 5 years in Montreal Cognitive Assessment (MoCA; min. 0, max. 30, higher score means better outcome) \[Time Frame: Annual assessments up to 5 years\]
Time frame: Annual assessments up to 5 years
Beck Depression Inventory
Depressive symptoms change from baseline to 5 year (BDI-II, min 0, max 63, higher score means worse outcome)
Time frame: Annual assessments up to 5 years
State-Trait Anxiety Inventory
Anxiety symptoms change from baseline to 5 year (STAI, min 20, max 80, higher score means worse outcome)
Time frame: Annual assessments up to 5 years
Questionnaire for Impulsive-Compulsive Disorders in Parkinson
Impulsivity change from baseline to 5 years (QUIP, min 0, max 112, higher score means worse outcome)
Time frame: Annual assessments up to 5 years
Pittsburgh Sleep Quality Index
Sleep Quality change (PSQI, min 0, max 21, higher score means poorer sleep quality)
Time frame: Annual assessments up to 5 years
Parkinson's Disease Questionnaire-8
Quality of life change from baseline to 5 years (PDQ-8, min 0, max 100, higher score means worse outcome)
Time frame: Annual assessments up to 5 years
Minnesota Multiphasic Personality Inventory 2-RF
Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T\>65 for clinical scales)
Time frame: Annual assessments up to 5 years
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico