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

NCT ID: NCT07173660

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-04-01

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.

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.

Conditions

Deep Brain Stimulation; Parkinson Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Expert Panel

An Italian expert panel of about 30 healthcare professionals, including neurosurgeons with expertise in deep brain stimulation for patients with Parkinson's disease.

Delphi study

Intervention Type: OTHER

A Delphi study will be conducted with several rounds up to stable expert consensus or dissensus

Interventions

Delphi study

A Delphi study will be conducted with several rounds up to stable expert consensus or dissensus

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• At least 5 years of clinical experience in the care of patients with Parkinson's disease, including involvement in deep brain stimulation (DBS) implantation (in both teaching and non-teaching settings).
• Prior participation in guideline development or authorship of at least one peer-reviewed publication on neuromodulation in Parkinson's disease.

Exclusion Criteria

• None.

Recruitment strategy:

• Purposive sampling will be applied to identify Italian panelists, primarily through a review of recent publications in the field of DBS for Parkinson's disease. Panelist selection will adhere to the predefined criteria, with deliberate efforts to ensure gender balance and broad geographical representation across Italy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Federico Longhini

Prof. Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Longhini, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and Intensive Care, Magna Graecia University, Catanzaro, Italy

Central Contacts

Federico Longhini, MD

Role: CONTACT

flonghini@unicz.it

00393475395967

Riccardo Ricciuti, MD

Role: CONTACT

rricciuti@scamilloforlanini.rm.it

0039 06 58704681

Other Identifiers

DBS Consensus

Identifier Type: -

Identifier Source: org_study_id