Stellate Ganglion Block in Patients With Advanced Primary Parkinson's Disease: a Small, Open, Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Improved MDS-UPDRS scale scoring
研究概览
简要总结
At present, there are no reports on the application of stellate ganglion block in the treatment of Parkinson's disease patients at home and abroad. Based on the preliminary clinical observation, this project intends to apply stellate ganglion block in the treatment of patients with intermediate and advanced Parkinson's disease through an open, randomized controlled small sample clinical study. To determine whether stellate ganglion block can effectively improve motor symptoms and non-motor symptoms in patients with primary advanced Parkinson's disease.
详细描述
Parkinson's disease (PD) is a relatively common degenerative disease of the central nervous system. In the past few decades, China's population has increased significantly, resulting in a rapid increase in the number of elderly people. According to the 2016 Global Burden of Disease study, the number of PD patients in China accounts for about 23% of the global PD population. By the end of 2020, the estimated number of people living with Parkinson's disease in China is about 3.62 million, and it is expected that by 2030, 50% of the world's PD patients will be Chinese. The main manifestations of Parkinson's disease are motor symptoms such as bradykinesia, myotonia and tremor, and non-motor symptoms such as autonomic nervous dysfunction, sleep disturbance and anosmia.
Both motor symptoms and non-motor symptoms can significantly affect patients' quality of life. At present, the domestic and foreign treatment guidelines for Parkinson's disease still prefer drug therapy represented by dopa. However, in the middle and late stages of the disease, side effects such as symptom fluctuation or hyperactivity disorder complicated by long-term drug use gradually appear, and the efficacy of patients on levodopa declines, which seriously affects the quality of life of patients. For patients with advanced Parkinson's disease, current anti-Parkinson's guidelines advocate a combination of drug therapy and non-drug therapy. As a major non-drug treatment for Parkinson's disease, deep brain stimulation (DBS) has limited its wide clinical application due to its complex, invasive, expensive, and many side effects, while conventional rehabilitation therapy is limited to functional exercise such as speech and swallowing, with limited efficacy. Therefore, the search for new treatments for Parkinson's disease is imperative.
At present, there are no reports about the application of SGB in the treatment of patients with Parkinson's disease at home and abroad. Based on the preliminary clinical observation, this study intends to apply SGB in the treatment of patients with advanced Parkinson's disease through an open, randomized controlled small sample clinical study, so as to confirm that SGB can effectively improve the motor symptoms and non-motor symptoms of patients with advanced Parkinson's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Parkinson's disease who met the diagnostic criteria for MDS as "probable PD" or" confirmed PD" in 2016
- •Inclusion criteria:
- •Patients with Parkinson's disease who met the diagnostic criteria of MDS as "probable PD" or" confirmed PD" in 2016;
- •The patient or his/her legal guardian agrees to participate in the study and signs the informed consent;
- •Hoehn-yahr (H&Y) 2.5 ~ 5;
排除标准
- •Allergic to local anesthetic drugs;
- •Unable to cooperate with motor or non-motor function monitoring;
- •Patients with Parkinson's superposition syndrome, such as cortical basal ganglia degeneration, lewy body dementia, multisystem atrophy and progressive supranuclear palsy, were excluded; Patients with secondary Parkinson's disease, such as vascular Parkinson's disease, drug toxicity or traumatic Parkinson's disease;
- •Refuse to sign the consent form.
研究组 & 干预措施
Parkinson's disease group
Diagnostic criteria: Patients with Parkinson's disease who met the diagnostic criteria for MDS as "probable PD" or" confirmed PD" in 2016
Inclusion criteria:
- Age 40-85;
- Patients with Parkinson's disease who met the diagnostic criteria of MDS as "probable PD" or" confirmed PD" in 2016;
- The patient or his/her legal guardian agrees to participate in the study and signs the informed consent;
- Hoehn-yahr (H&Y) 3 ~ 5;
干预措施: Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs） (Diagnostic Test)
Non-parkinson's disease group
Exclusion criteria:
- Allergic to local anesthetic drugs;
- Unable to cooperate with motor or non-motor function monitoring;
- Patients with Parkinson's superposition syndrome, such as cortical basal ganglia degeneration, lewy body dementia, multisystem atrophy and progressive supranuclear palsy, were excluded; Patients with secondary Parkinson's disease, such as vascular Parkinson's disease, drug toxicity or traumatic Parkinson's disease;
- Refuse to sign the consent form.
干预措施: Treatment （Oral standard anti-Parkinson's drugs） (Diagnostic Test)
结局指标
主要结局
Improved MDS-UPDRS scale scoring
时间窗: 12 weeks
The revised Movement Disorders Association Unified Parkinson's Disease Rating Scale has four major components, all of which include both physician and patient aspects. The first component is psychological, behavioral and emotional. The second part is daily life activities; The third part is motor symptoms; The fourth part is complications.
次要结局
- H&Y classification (Classification of Parkinson's disease)(12 weeks)
- LDE (Levodopa Equivalent dose)(12 weeks)
- Hamilton Anxiety Scale (HAMA)(12 weeks)
- Parkinson's Disease Sleep Scale (PDSS)(12 weeks)
- Pdq-39 (Self-rating Scale for clinical evaluation of quality of life in patients with Kinson disease)(12 weeks)
- NMSS (Non-motor Symptom Evaluation Scale)(12 weeks)
- Montreal Cognitive Assessment Scale(12 weeks)
研究者
Gao Xiaoya
Chief Physician
Zhujiang Hospital