Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:32 AM
Study NCT ID:
NCT07173660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease
Sponsor:
University Magna Graecia
Organization:
Study Overview
Official Title:
Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease - A Delphi Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DBS_Consensus
Brief Summary:
Deep brain stimulation (DBS) has become a cornerstone therapy for advanced Parkinson's disease (PD), showing superior outcomes over best medical treatment in randomized clinical trials. By delivering adjustable electrical stimulation to key basal ganglia targets, DBS improves tremor, rigidity, bradykinesia, and motor fluctuations, while also reducing dopaminergic medication requirements. Its success, however, depends not only on precise surgical targeting but also on careful patient selection, multidisciplinary planning, and structured long-term follow-up.
In Italy, PD affects nearly 176,000 individuals, of whom an estimated 2-4.5% are potential candidates for DBS. A national survey conducted by the Italian Neurosurgery Society (SINch) revealed marked heterogeneity in surgical approaches, target selection, and team composition across DBS centers-reflecting similar international variability. Yet, clear national indications and guidelines have not been established. To address this gap, we conducted an expert consensus using the Delphi methodology.
In Italy, PD affects nearly 176,000 individuals, of whom an estimated 2-4.5% are potential candidates for DBS. A national survey conducted by the Italian Neurosurgery Society (SINch) revealed marked heterogeneity in surgical approaches, target selection, and team composition across DBS centers-reflecting similar international variability. Yet, clear national indications and guidelines have not been established. To address this gap, we conducted an expert consensus using the Delphi methodology.
Detailed Description:
Deep brain stimulation (DBS) has become a cornerstone therapy for advanced Parkinson's disease (PD), consistently showing superior outcomes over best medical treatment in randomized clinical trials. By delivering adjustable electrical stimulation to specific basal ganglia targets, DBS provides sustained improvement in cardinal motor symptoms such as tremor, rigidity, and bradykinesia, while also mitigating motor fluctuations and dyskinesias. It often enables a substantial reduction in dopaminergic medication requirements, thereby decreasing treatment-related side effects and improving quality of life. Nonetheless, the success of DBS relies not only on accurate surgical targeting but also on careful patient selection, multidisciplinary planning, and long-term follow-up.
In Italy, PD affects nearly 176,000 individuals, of whom an estimated 2-4.5% may be suitable candidates for DBS. Despite this, effective implementation remains challenging. A national survey by the Italian Neurosurgery Society (SINch) revealed marked heterogeneity among DBS centers, particularly in surgical approaches, target selection, perioperative protocols, and team composition. While such variability mirrors international patterns, in Italy it is compounded by the absence of nationally endorsed guidelines or standardized care pathways. This lack of uniformity risks inequities in access, indications, and outcomes, raising concerns about quality of care and resource allocation within the national healthcare system.
Developing clear, evidence-based recommendations is therefore of paramount importance. Standardized indications and procedural frameworks would support patient selection, harmonize surgical practice, and guide multidisciplinary teams in delivering high-quality long-term care. Moreover, national guidelines would facilitate benchmarking across centers, promote training and education, and ensure equitable access to state-of-the-art treatment for all eligible patients.
To address these needs, we convened a panel of Italian experts in functional neurosurgery. Using the Delphi consensus methodology, we systematically gathered, refined, and integrated expert opinions on key aspects of DBS therapy for PD, with the aim of establishing practical, consensus-based recommendations tailored to the Italian healthcare setting.
In Italy, PD affects nearly 176,000 individuals, of whom an estimated 2-4.5% may be suitable candidates for DBS. Despite this, effective implementation remains challenging. A national survey by the Italian Neurosurgery Society (SINch) revealed marked heterogeneity among DBS centers, particularly in surgical approaches, target selection, perioperative protocols, and team composition. While such variability mirrors international patterns, in Italy it is compounded by the absence of nationally endorsed guidelines or standardized care pathways. This lack of uniformity risks inequities in access, indications, and outcomes, raising concerns about quality of care and resource allocation within the national healthcare system.
Developing clear, evidence-based recommendations is therefore of paramount importance. Standardized indications and procedural frameworks would support patient selection, harmonize surgical practice, and guide multidisciplinary teams in delivering high-quality long-term care. Moreover, national guidelines would facilitate benchmarking across centers, promote training and education, and ensure equitable access to state-of-the-art treatment for all eligible patients.
To address these needs, we convened a panel of Italian experts in functional neurosurgery. Using the Delphi consensus methodology, we systematically gathered, refined, and integrated expert opinions on key aspects of DBS therapy for PD, with the aim of establishing practical, consensus-based recommendations tailored to the Italian healthcare setting.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: