Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease (DBS Consensus)

University Magna Graecia

Status: Not yet enrolling

Conditions: Parkinson Disease; Deep Brain Stimulation

Treatments: Other: Delphi study

Study type: Observational

Funder types: Other

Identifiers

NCT07173660

DBS Consensus

Details and patient eligibility

About

Deep brain stimulation (DBS) has become a cornerstone therapy for advanced Parkinson's disease (PD), demonstrating superior outcomes compared with best medical treatment in randomized clinical trials. By delivering adjustable electrical stimulation to key basal ganglia targets, DBS effectively improves tremor, rigidity, bradykinesia, and motor fluctuations, while also reducing dopaminergic medication requirements. The success of DBS, however, depends not only on precise surgical targeting but also on careful patient selection, multidisciplinary planning, and structured long-term follow-up care.

Epidemiological data indicate that in Italy, PD affects nearly 176,000 individuals, of whom approximately 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, mirroring similar international variability. However, clear national indications and guidelines have not yet been established in Italy. To address this gap, we conducted an expert consensus using the Delphi methodology.

Full description

Deep brain stimulation (DBS) has become a cornerstone therapy for advanced Parkinson's disease (PD), consistently demonstrating superior outcomes compared with 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. In addition, DBS often allows for a substantial reduction in dopaminergic medication requirements, thereby decreasing treatment-related side effects and improving quality of life. Despite these benefits, the success of DBS depends not only on accurate surgical targeting but also on careful patient selection, multidisciplinary planning, and long-term postoperative follow-up.

Epidemiological data suggest that in Italy nearly 176,000 individuals are living with PD, of whom an estimated 2-4.5% may be suitable candidates for DBS. Nonetheless, the effective implementation of this therapy remains challenging. A national survey conducted by the Italian Neurosurgery Society (SINch) highlighted a high degree of heterogeneity among Italian DBS centers, particularly regarding surgical approaches, target selection, perioperative protocols, and team composition. Such variability reflects similar patterns observed internationally, but in Italy it is compounded by the absence of nationally endorsed guidelines or standardized care pathways. This lack of uniformity can lead to differences in access, indications, and clinical outcomes, raising concerns about equity of care and optimal resource allocation across the national healthcare system.

In this context, the development of clear, evidence-based, and widely accepted recommendations is of paramount importance. Standardized indications and procedural frameworks would support clinicians in patient selection, harmonize surgical practice, and guide multidisciplinary teams in delivering high-quality long-term care. Moreover, such guidelines would facilitate benchmarking across centers, promote training and education, and ultimately ensure that all eligible patients have equitable access to state-of-the-art treatment.

To address these needs, we convened a panel of Italian experts in functional neurosurgery. Using the Delphi consensus methodology, we sought to systematically gather, refine, and integrate expert opinions on the key aspects of DBS therapy for PD, with the goal of establishing practical, consensus-based recommendations tailored to the Italian healthcare setting.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthcare professionals will be selected as panelists based on the following criteria:

Inclusion criteria:

• at least 5 years of clinical experience, with care for patients affected by Parkinonson's Disease and implantation of Deep Brain Stimulation (teaching and non-teaching);
• participation in development of a guideline or authorship of at least one peer reviewed published paper in neuromodulation in patients with Parkinson's Disease.

Exclusion criteria:

- none

Purposive sampling will be utilized to recruit italian panelists by reviewing recent publications in the field of deep brain stimulation in patients with parkinson's disease.

Selection of panelists will be guided by predefined criteria, with deliberate efforts to ensure a balance in gender and geographical representation.

Trial design

30 participants in 1 patient group

Expert Panel

Description:

An italia expert panel of around 30 healthcare professionals representing neurosurgeons with expertise in the field of deep brain stimulation in patients affected by Parkinsonn's Disease.

Treatment:

Other: Delphi study