An observational study in Deep Brain Stimulation and Parkinson Disease, sponsored by University Magna Graecia. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by University Magna Graecia · Observational
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 30 is below the median of 96 across 1,085 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University Magna Graecia is the lead sponsor of 75 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthcare professionals representing italian neurosurgeons with expertise in the field of deep brain stimulation of patients with Parkinson's disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Panelist selection
Healthcare professionals will be recruited as panelists based on the following predefined criteria:
Inclusion criteria:
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.
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
A Delphi study will be conducted with several rounds up to stable expert consensus or dissensus
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.
Time frame: 3-6 months
No study locations are listed for this record.
Plan to share: No — Due to the study design (expert consensus), individual patient data do not require to be shared
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for Nov 2025, 2 months later.
Of 378 non-industry observational studies under Parkinson Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 133. This study's planned 2 months is below that.
Counting every sponsor, half of 438 studies reached it within 47 months; a quarter within 22 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Magna Graecia