Parkinson Disease
Conditions
Keywords
Parkinson disease, Deep Brain Stimulation, Cognitive dysfunction, Mood, Anxiety, Quality of life
Brief summary
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.
Interventions
DIAGNOSTIC_TESTClinical examinations and clinical scales administration
Psychometric assessment of cognitive and behavioral outcomes
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
* Parkinson's disease patients candidates for DBS of the subthalamic nucleus * Parkinson's disease patients with best medical treatment
Exclusion criteria
* patients unable to complete study assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term characterization of DBS-STN on cognitive outcomes | Annual assessments up to 5 years | Cognitive impairment change from baseline until 5 years in Montreal Cognitive Assessment (MoCA; min. 0, max. 30, higher score means better outcome) \[Time Frame: Annual assessments up to 5 years\] |
| Beck Depression Inventory | Annual assessments up to 5 years | Depressive symptoms change from baseline to 5 year (BDI-II, min 0, max 63, higher score means worse outcome) |
| State-Trait Anxiety Inventory | Annual assessments up to 5 years | Anxiety symptoms change from baseline to 5 year (STAI, min 20, max 80, higher score means worse outcome) |
| Questionnaire for Impulsive-Compulsive Disorders in Parkinson | Annual assessments up to 5 years | Impulsivity change from baseline to 5 years (QUIP, min 0, max 112, higher score means worse outcome) |
| Pittsburgh Sleep Quality Index | Annual assessments up to 5 years | Sleep Quality change (PSQI, min 0, max 21, higher score means poorer sleep quality) |
| Parkinson's Disease Questionnaire-8 | Annual assessments up to 5 years | Quality of life change from baseline to 5 years (PDQ-8, min 0, max 100, higher score means worse outcome) |
| Minnesota Multiphasic Personality Inventory 2-RF | Annual assessments up to 5 years | Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T\>65 for clinical scales) |
Countries
Italy
Contacts
Primary ContactFabiana Ruggiero, Dr
Backup ContactEleonora Zirone, Dr
Outcome results
None listed