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NCT Number: NCT06329726

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

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.

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Key information

Conditions

Parkinson Disease Anxiety Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20135, Italy

Location status: Recruiting

Location contact

Eleonora Zirone, Dr

CONTACT

[email protected]

0255038671 ext. 0039

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical examinations and clinical scales administration

Diagnostic Test

Psychometric assessment of cognitive and behavioral outcomes

Primary outcomes

  1. 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]

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonora Zirone, Dr

CONTACT

[email protected]

0255038671 ext. +39

Fabiana Ruggiero, Dr

CONTACT

[email protected]

0255033621 ext. +39

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Important dates

Study start
2021
Primary completion
2031
Study completion
2032
First posted
Mar 26, 2024
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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