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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06329726
Other study ID # NeuroPsico_DBS&PD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 13, 2021
Est. completion date December 15, 2032

Study information

Verified date February 2024
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Fabiana Ruggiero, Dr
Phone 0255033621
Email fabiana.ruggiero@policlinico.mi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date December 15, 2032
Est. primary completion date December 15, 2031
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Clinical examinations and clinical scales administration
Psychometric assessment of cognitive and behavioral outcomes

Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Lombardia

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary Pittsburgh Sleep Quality Index Sleep Quality change (PSQI, min 0, max 21, higher score means poorer sleep quality) Annual assessments up to 5 years
Primary 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
Primary Minnesota Multiphasic Personality Inventory 2-RF Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T>65 for clinical scales) Annual assessments up to 5 years
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