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

NCT07173660 | Not Yet Recruiting

• 1 other identifier: DBS Consensus
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deep Brain Stimulation; Parkinson Disease

Keywords

Expert Consensus; Neurosurgery

Outcome Measures

Primary Outcomes (1)

• Consensus use of Deep Brain Stimulation in Parkinson's Disease

  A diverse panel of experts from across Italy, identified through pre-specified qualification criteria, will participate in iterative Delphi rounds to develop consensus on the indications and parameters of deep brain stimulation for Parkinson's disease.

  3-6 months

Study Arms (1)

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.

Other: Delphi study

Interventions

Delphi study OTHER

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

Expert Panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare professionals representing italian neurosurgeons with expertise in the field of deep brain stimulation of patients with Parkinson's disease.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Magna Graecia: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Federico Longhini, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Longhini, MD

CONTACT

00393475395967; flonghini@unicz.it

Riccardo Ricciuti, MD

CONTACT

0039 06 58704681; rricciuti@scamilloforlanini.rm.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 15, 2025
• Study Start: September 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: April 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share