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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Deep brain stimulation surgery

Treatment groups

90 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Ministry of Health, Italy

Collaborator

Azienda Ospedaliero-Universitaria di Modena

Collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator