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

March 21, 2024 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Lombardia
      • Milan, Lombardia, Italy, 20135
        • Recruiting
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of Parkinson's disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD - undergone DBS
Patients with Parkinson's disease treated with DBS of the subthalamic nucleus
Diagnostic test: Clinical examinations and clinical scales administration
Psychometric assessment of cognitive and behavioral outcomes
PD - not undergone DBS
Patients with Parkinson's disease not treated with DBS
Diagnostic test: Clinical examinations and clinical scales administration
Psychometric assessment of cognitive and behavioral outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term characterization of DBS-STN on cognitive outcomes
Time Frame: 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]
Annual assessments up to 5 years
Beck Depression Inventory
Time Frame: 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)
Annual assessments up to 5 years
State-Trait Anxiety Inventory
Time Frame: Annual assessments up to 5 years
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
Time Frame: Annual assessments up to 5 years
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
Time Frame: Annual assessments up to 5 years
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
Time Frame: 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)
Annual assessments up to 5 years
Minnesota Multiphasic Personality Inventory 2-RF
Time Frame: Annual assessments up to 5 years
Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T>65 for clinical scales)
Annual assessments up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Francesca Mameli, Dr, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Estimated)

December 15, 2031

Study Completion (Estimated)

December 15, 2032

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeuroPsico_DBS&PD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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