Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Diagnostic Test: Clinical examinations and clinical scales administration
- Registration Number
- NCT06329726
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- Parkinson's disease patients candidates for DBS of the subthalamic nucleus
- Parkinson's disease patients with best medical treatment
- patients unable to complete study assessments
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PD - undergone DBS Clinical examinations and clinical scales administration Patients with Parkinson's disease treated with DBS of the subthalamic nucleus PD - not undergone DBS Clinical examinations and clinical scales administration Patients with Parkinson's disease not treated with DBS
- Primary Outcome Measures
Name Time Method 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)
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)
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)
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)
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)
Pittsburgh Sleep Quality Index Annual assessments up to 5 years Sleep Quality change (PSQI, min 0, max 21, higher score means poorer sleep quality)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milan, Lombardia, Italy