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

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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Key information

Conditions

Parkinson Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Bove, MD, PhD

CONTACT

[email protected]

+390630154303

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

Azienda Ospedaliero-Universitaria di Modena
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Ministry of Health, Italy

Registry information

Official study 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

Acronym: BRAIN-DBS-GAIN

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 29, 2026
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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