Parkinson DiseaseNCT06329726
Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease
An observational study of Parkinson Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Clinical examinations and clinical scales administration
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 13 Dec 2021to 15 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients with diagnosis of Parkinson's disease
Who may be able to join
- Parkinson's disease patients candidates for DBS of the subthalamic nucleus
- Parkinson's disease patients with best medical treatment
Who cannot join
- patients unable to complete study assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20135
Eleonora Zirone, Dr, 0255038671 ext. 0039, eleonora.zirone@policlinico.mi.it
About this study
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
- Being tested
- Clinical examinations and clinical scales administration
- Keywords
- Parkinson disease, Deep Brain Stimulation, Cognitive dysfunction, Mood, Anxiety, Quality of life
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinations and clinical scales administrationDiagnostic test
Psychometric assessment of cognitive and behavioral outcomes
| Study group | Role | What they receive |
|---|---|---|
| PD - undergone DBS | Patients with Parkinson's disease treated with DBS of the subthalamic nucleus Receives: Diagnostic Test: Clinical examinations and clinical scales administration | |
| PD - not undergone DBS | Patients with Parkinson's disease not treated with DBS Receives: Diagnostic Test: Clinical examinations and clinical scales administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Annual assessments up to 5 years
Pittsburgh Sleep Quality Index
Sleep Quality change (PSQI, min 0, max 21, higher score means poorer sleep quality)
Measured: 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)
Measured: 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)
Measured: Annual assessments up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start13 Dec 2021
- Primary completion15 Dec 2031 (estimated)
- Study completion15 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Mameli, Dr, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329726
- Sponsor's protocol ID
- NeuroPsico_DBS&PD
- Status last verified
- Feb 2024
- First submitted
- 6 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mellace D, Mameli F, Ruggiero F, Cogiamanian F, Borellini L, De Sandi A, Marfoli A, Zirone E, Mailland E, Pirola E, Ampollini AM, Remore LG, Locatelli M, Priori A, Barbieri S, Ferrucci R. Triple perspective: assessing deep brain stimulation outcomes in Parkinson's disease. BMC Neurol. 2025 Oct 14;25(1):426. doi: 10.1186/s12883-025-04455-3.
PubMed 41088049
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Behavioral and Cognitive Outcomes of Deep Brain Stimulation in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06329726
- Acronym / sponsor ID
- NeuroPsico_DBS&PD
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Deep Brain Stimulation, Cognitive dysfunction, Mood, Anxiety, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 15 Dec 2031 (estimated)
- Study completion
- 15 Dec 2032 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD - undergone DBS | – | Diagnostic Test: Clinical examinations and clinical scales administrationPatients with Parkinson's disease treated with DBS of the subthalamic nucleus |
| PD - not undergone DBS | – | Diagnostic Test: Clinical examinations and clinical scales administrationPatients with Parkinson's disease not treated with DBS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of Parkinson's disease
Key inclusion criteria (2 listed)
- Parkinson's disease patients candidates for DBS of the subthalamic nucleus
- Parkinson's disease patients with best medical treatment
Key exclusion criteria (1 listed)
- patients unable to complete study assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examinations and clinical scales administrationPsychometric assessment of cognitive and behavioral outcomes | Diagnostic test | PD - not undergone DBS, PD - undergone DBS |
Primary outcome
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]
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 41088049Mellace D, Mameli F, Ruggiero F, Cogiamanian F, Borellini L, De Sandi A, Marfoli A, Zirone E, Mailland E, Pirola E, Ampollini AM, Remore LG, Locatelli M, Priori A, Barbieri S, Ferrucci R. Triple perspective: assessing deep brain stimulation outcomes in Parkinson's disease. BMC Neurol. 2025 Oct 14;25(1):426. doi: 10.1186/s12883-025-04455-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Mameli, Dr principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabiana Ruggiero, Dr (0255033621 ext. +39, fabiana.ruggiero@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term characterization of DBS-STN on cognitive outcomes (time frame: Annual assessments up to 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06329726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.