Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease
NCT ID: NCT06176404
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
84 participants
INTERVENTIONAL
2021-02-01
2023-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease
NCT06226415
Investigation of Potential Mechanisms in Stellate Ganglion Block in Individuals With Cerebral Small Vessel Disease
NCT06301711
Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease
NCT06319495
Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients
NCT06228170
Efficacy of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
NCT06225076
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The comparison group
The study lasted 20d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.
Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.
Rehabilitation therapy
The study lasted 20d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.
Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.
The observation group
The study lasted 20d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.
Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.
Based on the invention above, the patients in the observation group were provided with SGB, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).
Stellate ganglion block
Based on the invention above, the patients in the observation group were provided with SGB, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for SGB. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Rehabilitation therapy
The study lasted 20d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.
Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stellate ganglion block
Based on the invention above, the patients in the observation group were provided with SGB, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for SGB. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Rehabilitation therapy
The study lasted 20d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.
Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding (NGT) was provided.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meeting the diagnostic criteria for cerebral small vessel disease Imaging proposed in 2013 by the international cerebral small vessel disease Expert Group, and the "Consensus on Diagnosis and Treatment of Cerebral Small Vessel Disease in China" in 2017.
* Dysphagia confirmed by Videofluoroscopic Swallowing Study
* Mini-Mental State Examination (MMSE)\<27, indicating the existence of cognitive impairment.
* No history of prior stroke.
* Stable vital signs.
Exclusion Criteria
* Cognitive impairment that might be caused by other diseases, such as Alzheimer's disease, Parkinson's disease, brain injury, etc.
* Neurological blockade contraindications such as bleeding tendency, blocked site infection.
* MMSE\<10, or unable to successfully finish the assessment of this study (Patients with severe mental illness or intellectual disability might have difficulty to cooperate with the assessment).
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zeng Changhao
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zeng Changhao
Research Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nieto Luis, Master
Role: PRINCIPAL_INVESTIGATOR
Site Coordinator of United Medical Group located in Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhen Da No.1 Fushu Hos.
Huabei, , China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zeng H, Zhao W, Fang L, Pan H, Huang S, Zeng X. Effect of Stellate Ganglion Block on Dysphagia and Cognitive Impairment in Cerebral Small Vessel Disease: A Randomized Controlled Study. J Speech Lang Hear Res. 2024 Oct 8;67(10):3660-3672. doi: 10.1044/2024_JSLHR-24-00145. Epub 2024 Sep 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NXXG-SGB-jiu
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.