Clinical Study of Stellate Ganglion Block in Treatment of Patients With Advanced Primary Parkinson's Disease
Stellate Ganglion Block in Patients With Advanced Primary Parkinson's Disease: a Small, Open, Randomized Controlled Clinical Study
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2023
CompletedStudy Start
First participant enrolled
July 28, 2023
CompletedFirst Posted
Study publicly available on registry
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJanuary 31, 2024
January 1, 2024
11 months
July 13, 2023
January 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
NMSS (Non-motor Symptom Evaluation Scale)
12 weeks
Pdq-39 (Self-rating Scale for clinical evaluation of quality of life in patients with Kinson disease)
12 weeks
H&Y classification (Classification of Parkinson's disease)
12 weeks
LDE (Levodopa Equivalent dose)
12 weeks
Hamilton Anxiety Scale (HAMA)
12 weeks
- +2 more secondary outcomes
Study Arms (2)
Parkinson's disease group
EXPERIMENTALDiagnostic 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;
Non-parkinson's disease group
EXPERIMENTALExclusion 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.
Interventions
Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）
Treatment （Oral standard anti-Parkinson's drugs）
Eligibility Criteria
You may qualify if:
- Patients with Parkinson's disease who met the diagnostic criteria for MDS as "probable PD" or" confirmed PD" in 2016
- 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) 2.5 \~ 5;
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhujiang Hospiatal
Guangzhou, Guangdong, 510000, China
Related Publications (8)
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.
PMID: 34390510RESULTSantos-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.
PMID: 23890935RESULTJost 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.
PMID: 31290336RESULTStozek 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. Epub 2015 Dec 10.
PMID: 26661467RESULTBi 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.
PMID: 25331477RESULTDai 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.
PMID: 34749669RESULTUchida 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.
PMID: 12208186RESULTMoon 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.
PMID: 23342209RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoya Gao, doctor
Southern Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician
Study Record Dates
First Submitted
July 13, 2023
First Posted
November 1, 2023
Study Start
July 28, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
January 31, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share