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

NCT06329726 | Recruiting

• 1 other identifier: NeuroPsico_DBS&PD
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Deep Brain Stimulation; Cognitive dysfunction; Mood; Anxiety; Quality of life

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• Pittsburgh Sleep Quality Index

  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

  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

  Personality change from baseline to 5 years (MMPI-2-RF, cut-off: T\>65 for clinical scales)

  Annual assessments up to 5 years

Study Arms (2)

PD - undergone DBS

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

Diagnostic Test: Clinical examinations and clinical scales administration

PD - not undergone DBS

Patients with Parkinson's disease not treated with DBS

Diagnostic Test: Clinical examinations and clinical scales administration

Interventions

Clinical examinations and clinical scales administration DIAGNOSTIC_TEST

Psychometric assessment of cognitive and behavioral outcomes

PD - not undergone DBS; PD - undergone DBS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of Parkinson's disease

You may qualify if:

• Parkinson's disease patients candidates for DBS of the subthalamic nucleus
• Parkinson's disease patients with best medical treatment

You may not qualify if:

• patients unable to complete study assessments

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20135, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction; Anxiety Disorders

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Francesca Mameli, Dr

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabiana Ruggiero, Dr

CONTACT

0255033621; fabiana.ruggiero@policlinico.mi.it

Eleonora Zirone, Dr

CONTACT

0255038671; eleonora.zirone@policlinico.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 26, 2024
• Study Start: December 13, 2021
• Primary Completion (Estimated): December 15, 2031
• Study Completion (Estimated): December 15, 2032
• Last Updated: March 26, 2024

Record last verified: 2024-02

Locations

IT (1)