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NCT07673783Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 29 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
90 (estimated)
First submitted
23 Jun 2026
Start date
1 Sept 2026
Primary completion date
29 Feb 2028
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT07673783

What you commit to

  • Study type: Observational
  • Planned participants: 90
  • From 1 Sept 2026 to the primary completion date, 29 Feb 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous neurosurgical interventions for PD;
  • chronic intake of anti-inflammatory drugs (e.g. steroids or NSAIDs).

Other illness

  • moderate or severe cognitive impairment (score \< 24 on the Mini-Mental State Examination);
  • severe psychiatric symptoms (e.g., psychosis, major depression);
  • ongoing inflammatory or autoimmune diseases;
  • chronic infectious diseases;

Other

  • inability to express an informed consent;
  • pregnancy;
  • active neoplasms;

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.