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| Name | Class |
|---|---|
| Ministry of Health, Italy | OTHER_GOV |
| Azienda Ospedaliero-Universitaria di Modena | OTHER |
| Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | OTHER |
The aim of the study is to characterize the neuroinflammatory effects of subthalamic deep brain stimulation in patients with Parkinson's disease, by analyzing changes in blood neuroinflammatory and neurodegenerative biomarkers before and after surgery (at 6 and 12 months, respectively), and comparing the changes in blood biomarkers levels with a control group of patients with advanced PD on best medical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS group | Patients with advanced Parkinson's disease who will undergo deep brain stimulation surgery, according to clinical practice, will be assigned to this group. |
| |
| Control group | Patients with advanced Parkinson's disease on best medical treatment, potentially eligible for DBS but who refuse this therapy, will be allocated in this group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation surgery | Device | The patients of DBS group will undergo surgical implantation of a system of deep brain stimulation in the subthalamic nucleus bilaterally, according to clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize neuroinflammatory effects of deep brain stimulations | The main aim of the study is to characterize the neuroinflammatory effects of STN-DBS in PD patients, by analyzing changes in blood neuroinflammatory and neurodegenerative biomarkers before and after surgery (at 6 and 12 months, respectively), and comparing the changes in blood biomarkers levels with a control group of patients with advanced PD on best medical treatment. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Among patients attending outpatient clinics for Movement Disorders, 45 subjects with advanced PD candidate for STN-DBS surgery (according to common clinical practice) and 45 subjects with advanced PD on best medical treatment, potentially eligible for DBS but who refused this therapy, will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Bove, MD, PhD | Contact | +390630154303 | francesco.bove@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| francesco Bove | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38199508 | Background | Eser P, Kocabicak E, Bekar A, Temel Y. Insights into neuroinflammatory mechanisms of deep brain stimulation in Parkinson's disease. Exp Neurol. 2024 Apr;374:114684. doi: 10.1016/j.expneurol.2024.114684. Epub 2024 Jan 8. | |
| 39481497 | Background | McFleder RL, Musacchio T, Keller J, Knorr S, Petschner T, Chen JZ, Muthuraman M, Badr M, Harder-Rauschenberger L, Kremer F, Asci S, Steinhauser S, Karl AK, Brotchie JM, Koprich JB, Volkmann J, Ip CW. Deep brain stimulation halts Parkinson's disease-related immune dysregulation in the brain and peripheral blood. Brain Behav Immun. 2025 Jan;123:851-862. doi: 10.1016/j.bbi.2024.10.039. Epub 2024 Oct 29. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 36292973 | Background | Pinheiro Campos AC, Martinez RCR, Auada AVV, Lebrun I, Fonoff ET, Hamani C, Pagano RL. Effect of Subthalamic Stimulation and Electrode Implantation in the Striatal Microenvironment in a Parkinson's Disease Rat Model. Int J Mol Sci. 2022 Oct 11;23(20):12116. doi: 10.3390/ijms232012116. |
| 16999940 | Background | Temel Y, Visser-Vandewalle V, Kaplan S, Kozan R, Daemen MA, Blokland A, Schmitz C, Steinbusch HW. Protection of nigral cell death by bilateral subthalamic nucleus stimulation. Brain Res. 2006 Nov 20;1120(1):100-5. doi: 10.1016/j.brainres.2006.08.082. Epub 2006 Sep 26. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |