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

NCT ID: NCT06112392

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2024-06-30

Brief 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.

Detailed 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.

Conditions

Stellate Ganglion; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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:

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) 3 ~ 5;

Group Type: EXPERIMENTAL

Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）

Intervention Type: DIAGNOSTIC_TEST

Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）

Non-parkinson's disease group

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.

Group Type: EXPERIMENTAL

Treatment （Oral standard anti-Parkinson's drugs）

Intervention Type: DIAGNOSTIC_TEST

Treatment （Oral standard anti-Parkinson's drugs）

Interventions

Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）

Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）

Intervention Type: DIAGNOSTIC_TEST

Treatment （Oral standard anti-Parkinson's drugs）

Treatment （Oral standard anti-Parkinson's drugs）

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gao Xiaoya

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoya Gao, doctor

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Locations

Zhujiang Hospiatal

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoya Gao, doctor

Role: CONTACT

gaoxy23@126.com

86-18680282869

Kaitao Wang, graduate

Role: CONTACT

137783032@qq.com

86-18775317530

Facility Contacts

Xiaoya Gao

Role: primary

gaoxy23@126.com

86-18680282869

References

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 14.

Reference Type: RESULT

PMID: 34390510 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23890935 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31290336 (View on PubMed)

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Reference Type: RESULT

PMID: 26661467 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25331477 (View on PubMed)

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/s12871-021-01486-4.

Reference Type: RESULT

PMID: 34749669 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12208186 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23342209 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2022-KY-080-01

Identifier Type: -

Identifier Source: org_study_id