Stellate Ganglion Block in Patients With Advanced Primary Parkinson's Disease: a Small, Open, Randomized Controlled Clinical Study
Sponsor study identifier
interventional
38
1 country
1
Study Start
July 28, 2023
Actual (reported)Primary Completion
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 13, 2023
Actual (reported)July 28, 2023
Actual (reported)November 1, 2023
Actual (reported)June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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;
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.
Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）
Treatment （Oral standard anti-Parkinson's drugs）
Zhujiang Hospiatal
Guangzhou, Guangdong, 510000, China
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.
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.
Xiaoya Gao, doctor
Southern Medical University, China
First Submitted
July 13, 2023
First Posted
November 1, 2023
Study Start
July 28, 2023
Actual (reported)Primary Completion
June 30, 2024
Estimated (date passed)Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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. Epub 2015 Dec 10.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 31, 2024
Record last verified: 2024-01
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