Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients.

Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients: Insights Into Fluid Biomarkers of Neuroinflammation and Correlations With Clinical Outcomes

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07673783

Acronym

BRAIN-DBS-GAIN

Enrollment

Registered

2026-06-29

Start date

2026-09-01

Completion date

2028-02-29

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease (PD)

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.

Interventions

DEVICEDeep brain stimulation surgery

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 design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Inclusion criteria

* 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.

Exclusion criteria

* 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).

Design outcomes

Primary

Measure	Time frame	Description
To characterize neuroinflammatory effects of deep brain stimulations	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.

Contacts

CONTACTFrancesco Bove, MD, PhD

francesco.bove@policlinicogemelli.it+390630154303

PRINCIPAL_INVESTIGATORfrancesco Bove

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026