Clinical trial NCT06112392: Clinical Study of Stellate Ganglion Block in Treatment of Patients With Advanced Primary Parkinson's Disease
Official title: Stellate Ganglion Block in Patients With Advanced Primary Parkinson's Disease: a Small, Open, Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stellate Ganglion
Parkinson Disease
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improved MDS-UPDRS scale scoring
timeFrame: 12 weeks
Secondary outcomes:
measure: NMSS (Non-motor Symptom Evaluation Scale)
timeFrame: 12 weeks
measure: Pdq-39 (Self-rating Scale for clinical evaluation of quality of life in patients with Kinson disease)
timeFrame: 12 weeks
measure: H&Y classification (Classification of Parkinson's disease)
timeFrame: 12 weeks
measure: LDE (Levodopa Equivalent dose)
timeFrame: 12 weeks
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: 12 weeks
measure: Parkinson's Disease Sleep Scale (PDSS)
timeFrame: 12 weeks
measure: Montreal Cognitive Assessment Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospiatal
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Xiaoya Gao, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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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/s12871-021-01486-4.
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