Parkinson Disease (PD)BRAIN-DBS-GAINNCT07673783
Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients.
An observational study of Parkinson Disease (PD), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Deep brain stimulation surgery
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 29 Feb 2028
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- chronic infectious diseases;
- active neoplasms;
- chronic intake of anti-inflammatory drugs (e.g. steroids or NSAIDs).
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: Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients: Insights Into Fluid Biomarkers of Neuroinflammation and Correlations With Clinical Outcomes
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.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Deep brain stimulation surgery
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulation surgeryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Deep brain stimulation surgery | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy, Azienda Ospedaliero-Universitaria di Modena, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Responsible party
- Sponsor
- Investigators
- francesco Bove, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673783
- Sponsor's protocol ID
- 27623
- Acronym
- BRAIN-DBS-GAIN
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 38199508McFleder 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.
PubMed 39481497Pinheiro 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.
PubMed 36292973Temel 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.
PubMed 16999940
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients: Insights Into Fluid Biomarkers of Neuroinflammation and Correlations With Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07673783
- Acronym / sponsor ID
- BRAIN-DBS-GAIN / 27623
- Conditions
- Parkinson Disease (PD)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy, Azienda Ospedaliero-Universitaria di Modena, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 29 Jun 2026 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS group | – | Device: Deep brain stimulation surgeryPatients 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| Deep brain stimulation surgeryThe patients of DBS group will undergo surgical implantation of a system of deep brain stimulation in the subthalamic nucleus bilaterally, according to clinical practice. | Device | DBS group |
Primary outcome
To characterize neuroinflammatory effects of deep brain stimulations
Time frame: 12 months
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.
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 29 Jun 2026.
- Background: PubMed 38199508Eser 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.
- Background: PubMed 39481497McFleder 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.
- Background: PubMed 36292973Pinheiro 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.
- Background: PubMed 16999940Temel 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.
- Individual participant dataSharing planned: No
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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.
francesco Bove principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease (PD), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 inclusion and 9 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 29 Jun 2026. 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 Francesco Bove, MD, PhD (+390630154303, francesco.bove@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize neuroinflammatory effects of deep brain stimulations (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07673783, which also lists 4 linked publications.
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 29 Jun 2026.