Deep Brain StimulationDBS_ConsensusNCT07173660
Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease
An observational study of Deep Brain Stimulation and Parkinson Disease, run by University Magna Graecia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Brain Stimulation, Parkinson Disease
- What is being tested?
- Delphi study
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 1 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare professionals representing italian neurosurgeons with expertise in the field of deep brain stimulation of patients with Parkinson's disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease - A Delphi Study
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.
Read the 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
- Being tested
- Delphi study
- Keywords
- Expert Consensus, Neurosurgery
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delphi studyOther
A Delphi study will be conducted with several rounds up to stable expert consensus or dissensus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Delphi study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Anesthesia and Intensive Care, Magna Graecia University, Catanzaro, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173660
- Sponsor's protocol ID
- DBS Consensus
- Acronym
- DBS_Consensus
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the study design (expert consensus), individual patient data do not require to be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consensus Statements on Deep Brain Stimulation in Patients With Parkinson's Disease - A Delphi Study
- ClinicalTrials.gov ID
- NCT07173660
- Acronym / sponsor ID
- DBS_Consensus / DBS Consensus
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Keywords
- Expert Consensus, Neurosurgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expert Panel | – | Other: Delphi studyAn Italian expert panel of about 30 healthcare professionals, including neurosurgeons with expertise in deep brain stimulation for patients with Parkinson's disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare professionals representing italian neurosurgeons with expertise in the field of deep brain stimulation of patients with Parkinson's disease.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- None.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delphi studyA Delphi study will be conducted with several rounds up to stable expert consensus or dissensus | Other | Expert Panel |
Primary outcome
Consensus use of Deep Brain Stimulation in Parkinson's Disease
Time frame: 3-6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No. Due to the study design (expert consensus), individual patient data do not require to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Federico Longhini, MD principal investigator
Anesthesia and Intensive Care, Magna Graecia University, Catanzaro, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Brain Stimulation and Parkinson Disease, run by University Magna Graecia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Longhini, MD (00393475395967, flonghini@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus use of Deep Brain Stimulation in Parkinson's Disease (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.