Clinical Study of Stellate Ganglion Block in Treatment of Patients With Advanced Primary Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Stellate Ganglion Block in Patients With Advanced Primary Parkinson's Disease: a Small, Open, Randomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112392
• Other study ID #: 2022-KY-080-01
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Zhujiang Hospital
• Contact: Xiaoya Gao, doctor
• Phone: 86-18680282869
• Email: gaoxy23[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients with Parkinson's disease who met the diagnostic criteria for MDS as "probable PD" or" confirmed PD" in 2016

Inclusion criteria:

1. Age 40-85;

2. Patients with Parkinson's disease who met the diagnostic criteria of MDS as "probable PD" or" confirmed PD" in 2016;

3. The patient or his/her legal guardian agrees to participate in the study and signs the informed consent;

4. Hoehn-yahr (H&Y) 2.5 ~ 5;

Exclusion Criteria:

• 1. Allergic to local anesthetic drugs;

2. Unable to cooperate with motor or non-motor function monitoring;

3. 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;

4. Refuse to sign the consent form.

Related Conditions & MeSH terms

• Ganglion Cysts
• Parkinson Disease
• Stellate Ganglion

Intervention

Diagnostic Test:
• Treatment (Stellate ganglion block;Oral standard anti-Parkinson's drugs)
Treatment (Stellate ganglion block;Oral standard anti-Parkinson's drugs)
• Treatment (Oral standard anti-Parkinson's drugs)
Treatment (Oral standard anti-Parkinson's drugs)

Locations

Country	Name	City	State
China	Zhujiang Hospiatal	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

Bi Y, Wang B, Yin Z, Zhang G, Chen H, Wang M. [Effects of stellate ganglion block on AMP-ativated protein kinase and astrocyte in hippocampal neurons in postoperative aged rats]. Zhonghua Yi Xue Za Zhi. 2014 Jul 22;94(28):2222-6. Chinese. — View Citation

Dai D, Zheng B, Yu Z, Lin S, Tang Y, Chen M, Ke P, Zheng C, Chen Y, Wu X. Right stellate ganglion block improves learning and memory dysfunction and hippocampal injury in rats with sleep deprivation. BMC Anesthesiol. 2021 Nov 8;21(1):272. doi: 10.1186/s12 — View Citation

Jost WH, Buhmann C. The challenge of pain in the pharmacological management of Parkinson's disease. Expert Opin Pharmacother. 2019 Oct;20(15):1847-1854. doi: 10.1080/14656566.2019.1639672. Epub 2019 Jul 10. — View Citation

Moon HS, Chon JY, Lee SH, Ju YM, Sung CH. Long-term Results of Stellate Ganglion Block in Patients with Olfactory Dysfunction. Korean J Pain. 2013 Jan;26(1):57-61. doi: 10.3344/kjp.2013.26.1.57. Epub 2013 Jan 4. — View Citation

Qi S, Yin P, Wang L, Qu M, Kan GL, Zhang H, Zhang Q, Xiao Y, Deng Y, Dong Z, Shi Y, Meng J, Chan P, Wang Z. Prevalence of Parkinson's Disease: A Community-Based Study in China. Mov Disord. 2021 Dec;36(12):2940-2944. doi: 10.1002/mds.28762. Epub 2021 Aug 1 — View Citation

Santos-Garcia D, de la Fuente-Fernandez R. Impact of non-motor symptoms on health-related and perceived quality of life in Parkinson's disease. J Neurol Sci. 2013 Sep 15;332(1-2):136-40. doi: 10.1016/j.jns.2013.07.005. Epub 2013 Jul 25. — View Citation

Stozek J, Rudzinska M, Pustulka-Piwnik U, Szczudlik A. The effect of the rehabilitation program on balance, gait, physical performance and trunk rotation in Parkinson's disease. Aging Clin Exp Res. 2016 Dec;28(6):1169-1177. doi: 10.1007/s40520-015-0506-1. — View Citation

Uchida K, Tateda T, Hino H. Novel mechanism of action hypothesized for stellate ganglion block related to melatonin. Med Hypotheses. 2002 Oct;59(4):446-9. doi: 10.1016/s0306-9877(02)00158-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved MDS-UPDRS scale scoring	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.	12 weeks
Secondary	NMSS (Non-motor Symptom Evaluation Scale)	Non-motor Symptom Evaluation Scale, minimum value 0 points, maximum 360 points. The higher the score, the worse the condition.	12 weeks
Secondary	Pdq-39 (Self-rating Scale for clinical evaluation of quality of life in patients with Kinson disease)	Self-rating Scale for clinical evaluation of quality of life in patients with Kinson disease, minimum value 0 points, maximum 156 points. The higher the score, the worse the condition.	12 weeks
Secondary	H&Y classification (Classification of Parkinson's disease)	Classification of Parkinson's disease, minimum value 0 points, maximum 5 points. The higher the score, the worse the condition.	12 weeks
Secondary	LDE (Levodopa Equivalent dose)	Levodopa Equivalent dose, based on the dose of different anti-Parkinson's drugs. The higher the score, the worse the condition.	12 weeks
Secondary	Hamilton Anxiety Scale (HAMA)	Hamilton Anxiety Scale, minimum value 0 points, maximum 56 points. The higher the score, the worse the condition.	12 weeks
Secondary	Parkinson's Disease Sleep Scale (PDSS)	Parkinson's Disease Sleep Scale, minimum value 0 points, maximum 150 points. The higher the score, the better the patient.	12 weeks
Secondary	Montreal Cognitive Assessment Scale	Montreal Cognitive Assessment Scale, minimum value 0 points, maximum 30 points. The higher the score, the better the patient.	12 weeks