Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients. (BRAIN-DBS-GAIN)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Parkinson Disease (PD)

Treatments: Device: Deep brain stimulation surgery

Study type: Observational

Funder types: Other

Identifiers

NCT07673783

27623

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

90 participants in 2 patient groups

DBS group

Description:

Patients with advanced Parkinson's disease who will undergo deep brain stimulation surgery, according to clinical practice, will be assigned to this group.

Treatment:

Device: Deep brain stimulation surgery

Control group

Description:

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