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Not yet recruiting NCT07673783

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

— Observational Parkinson Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep brain stimulation surgery.
Who it may be relevant to
Registry conditions: Parkinson Disease (PD). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Device Deep 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.

Primary outcome measures

  • To characterize neuroinflammatory effects of deep brain stimulations [Time frame: 12 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Eser P, Kocabicak E, Bekar A, Temel Y. Insights into neuroinflammatory mechanisms of deep brain stimulation in Parkinson's disease. Exp Neurol. 2024 Apr;374:114684. doi: 10.1016/j.expneurol.2024.114684. Epub 2024 Jan 8. PMID 38199508
  • McFleder RL, Musacchio T, Keller J, Knorr S, Petschner T, Chen JZ, Muthuraman M, Badr M, Harder-Rauschenberger L, Kremer F, Asci S, Steinhauser S, Karl AK, Brotchie JM, Koprich JB, Volkmann J, Ip CW. Deep brain stimulation halts Parkinson's disease-related immune dysregulation in the brain and peripheral blood. Brain Behav Immun. 2025 Jan;123:851-862. doi: 10.1016/j.bbi.2024.10.039. Epub 2024 Oct PMID 39481497
  • Pinheiro Campos AC, Martinez RCR, Auada AVV, Lebrun I, Fonoff ET, Hamani C, Pagano RL. Effect of Subthalamic Stimulation and Electrode Implantation in the Striatal Microenvironment in a Parkinson's Disease Rat Model. Int J Mol Sci. 2022 Oct 11;23(20):12116. doi: 10.3390/ijms232012116. PMID 36292973
  • Temel Y, Visser-Vandewalle V, Kaplan S, Kozan R, Daemen MA, Blokland A, Schmitz C, Steinbusch HW. Protection of nigral cell death by bilateral subthalamic nucleus stimulation. Brain Res. 2006 Nov 20;1120(1):100-5. doi: 10.1016/j.brainres.2006.08.082. Epub 2006 Sep 26. PMID 16999940

Identifiers

NCT: NCT07673783 · 27623

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗