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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD - undergone DBS | Patients with Parkinson's disease treated with DBS of the subthalamic nucleus |
| |
| PD - not undergone DBS | Patients with Parkinson's disease not treated with DBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical examinations and clinical scales administration | Diagnostic Test | Psychometric assessment of cognitive and behavioral outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 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) | 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) | 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) | Annual assessments up to 5 years |
| Pittsburgh Sleep Quality Index | Sleep Quality change (PSQI, min 0, max 21, higher score means poorer sleep quality) | 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) | Annual assessments up to 5 years |
| Minnesota Multiphasic Personality Inventory 2-RF |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with diagnosis of Parkinson's disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabiana Ruggiero, Dr | Contact | 0255033621 | +39 | fabiana.ruggiero@policlinico.mi.it |
| Eleonora Zirone, Dr | Contact | 0255038671 | +39 | eleonora.zirone@policlinico.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesca Mameli, Dr | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Recruiting | Milan | Lombardy | 20135 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41088049 | Derived | Mellace D, Mameli F, Ruggiero F, Cogiamanian F, Borellini L, De Sandi A, Marfoli A, Zirone E, Mailland E, Pirola E, Ampollini AM, Remore LG, Locatelli M, Priori A, Barbieri S, Ferrucci R. Triple perspective: assessing deep brain stimulation outcomes in Parkinson's disease. BMC Neurol. 2025 Oct 14;25(1):426. doi: 10.1186/s12883-025-04455-3. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D060825 | Cognitive Dysfunction |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010808 | Physical Examination |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T>65 for clinical scales)
| Annual assessments up to 5 years |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |