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Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2022
See protocol details

Summary

Principal SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ContactFrancesco Bove, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 12, 2022

Actual date on which the first participant was enrolled.

The main objective of the study is to evaluate the improvement in quality of life after deep brain stimulation surgery with frameless technique by comparing the PDQ-39 scale score at baseline (before surgery) and one year after surgery.

Official TitleShort- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study
Principal SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ContactFrancesco Bove, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesParkinsonian Disorders

Criteria

Inclusion Criteria: * diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria; * patients who are candidates for deep brain stimulation intervention, according to the international criteria of the "Core assessment program for surgical interventional therapies in Parkinson's disease" (CAPSIT-PD). Exclusion Criteria: \- patients unable to give informed consent.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Flavia Torlizzi

Rome, ItalyOpen Flavia Torlizzi in Google Maps
Recruiting
One Study Center