To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Study of Stellate Ganglion Block in Treatment of Patients With Advanced Primary Parkinson's Disease
NCT ID:
NCT06112392
Condition:
Stellate Ganglion
Parkinson Disease
Conditions: Official terms:
Ganglion Cysts
Synovial Cyst
Parkinson Disease
Antiparkinson Agents
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）
Description:
Treatment （Stellate ganglion block；Oral standard anti-Parkinson's drugs）
Arm group label:
Parkinson's disease group
Intervention type:
Diagnostic Test
Intervention name:
Treatment （Oral standard anti-Parkinson's drugs）
Description:
Treatment （Oral standard anti-Parkinson's drugs）
Arm group label:
Non-parkinson's disease group
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.
Criteria for 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.
Gender:
All
Minimum age:
40 Years
Maximum age:
85 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Zhujiang Hospiatal
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoya Gao
Phone:
86-18680282869
Email:
gaoxy23@126.com
Start date:
July 28, 2023
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Zhujiang Hospital
Agency class:
Other
Source:
Zhujiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06112392
