Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients.
BRAIN-DBS-GAIN
1 other identifier
observational
90
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2026
CompletedFirst Posted
Study publicly available on registry
June 29, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2028
Study Completion
Last participant's last visit for all outcomes
February 29, 2028
June 29, 2026
June 1, 2026
1.5 years
June 23, 2026
June 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- clinically established diagnosis of PD according to the criteria of the Movement Disorder Society (MDS) (Postuma et al., Mov Disord 2015);
- a minimum disease duration of 4 years;
- eligibility for STN-DBS surgery according to Core Assessment Program for Surgical Interventional Therapies in PD (Defer et al., Mov Disord 1999);
- age between 18 and 75 years.
You may not qualify if:
- inability to express an informed consent;
- moderate or severe cognitive impairment (score \< 24 on the Mini-Mental State Examination);
- severe psychiatric symptoms (e.g., psychosis, major depression);
- previous neurosurgical interventions for PD;
- pregnancy;
- ongoing inflammatory or autoimmune diseases;
- chronic infectious diseases;
- active neoplasms;
- chronic intake of anti-inflammatory drugs (e.g. steroids or NSAIDs).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 38199508BACKGROUNDMcFleder 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.
PMID: 39481497BACKGROUNDPinheiro 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.
PMID: 36292973BACKGROUNDTemel 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.
PMID: 16999940BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
francesco Bove
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2026
First Posted
June 29, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
February 29, 2028
Study Completion (Estimated)
February 29, 2028
Last Updated
June 29, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share