Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329726
• Other study ID #: NeuroPsico_DBS&PD
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Parkinson Disease

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