Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical examinations and clinical scales administration.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 test Clinical examinations and clinical scales administration
Psychometric assessment of cognitive and behavioral outcomes
Primary outcome measures
- Long-term characterization of DBS-STN on cognitive outcomes [Time frame: Annual assessments up to 5 years]
- Beck Depression Inventory [Time frame: Annual assessments up to 5 years]
- State-Trait Anxiety Inventory [Time frame: Annual assessments up to 5 years]
- Questionnaire for Impulsive-Compulsive Disorders in Parkinson [Time frame: Annual assessments up to 5 years]
- Pittsburgh Sleep Quality Index [Time frame: Annual assessments up to 5 years]
- Parkinson's Disease Questionnaire-8 [Time frame: Annual assessments up to 5 years]
- Minnesota Multiphasic Personality Inventory 2-RF [Time frame: Annual assessments up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
Publications
- 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. PMID 41088049
Identifiers
NCT: NCT06329726 · NeuroPsico_DBS&PD