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

NCT ID: NCT06329726

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-13

Study Completion Date

2032-12-15

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PD - undergone DBS

Patients with Parkinson's disease treated with DBS of the subthalamic nucleus

Clinical examinations and clinical scales administration

Intervention Type DIAGNOSTIC_TEST

Psychometric assessment of cognitive and behavioral outcomes

PD - not undergone DBS

Patients with Parkinson's disease not treated with DBS

Clinical examinations and clinical scales administration

Intervention Type DIAGNOSTIC_TEST

Psychometric assessment of cognitive and behavioral outcomes

Interventions

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Clinical examinations and clinical scales administration

Psychometric assessment of cognitive and behavioral outcomes

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesca Mameli, Dr

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Fabiana Ruggiero, Dr

Role: CONTACT

0255033621 ext. +39

Eleonora Zirone, Dr

Role: CONTACT

0255038671 ext. +39

Facility Contacts

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Eleonora Zirone, Dr

Role: primary

0255038671 ext. 0039

Other Identifiers

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NeuroPsico_DBS&PD

Identifier Type: -

Identifier Source: org_study_id

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