Outlining Biological Effects of Subthalamic Deep Brain Stimulation in Parkinson's Disease Patients: Insights Into Fluid Biomarkers of Neuroinflammation and Correlations With Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- To characterize neuroinflammatory effects of deep brain stimulations
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
DBS group
Patients with advanced Parkinson's disease who will undergo deep brain stimulation surgery, according to clinical practice, will be assigned to this group.
干预措施: Deep brain stimulation surgery (Device)
Control group
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
结局指标
主要结局
To characterize neuroinflammatory effects of deep brain stimulations
时间窗: 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.
次要结局
未报告次要终点