Clinical trial NCT06176404: Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease
Official title: Stellate Ganglion Block in Cerebral Small Vessel Disease Patients With Dysphagia and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia
Cerebral Small Vessel Diseases
Cognitive Impairment
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective study was conducted on 84 CSVD patients with dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given SGB. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

Detailed description: In order to observe the effect of stellate ganglion block (SGB) on swallowing function, cognitive function and activities of daily living in patients with cerebral small vessel disease (CSVD), A prospective study was conducted on 84 CSVD patients with dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given SGB. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* 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:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* 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.

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 20
Secondary outcomes:
measure: Modified Barthel Index
timeFrame: day 1 and day 20
measure: Mini-Mental State Examination
timeFrame: day 1 and day 20
measure: Swallowing duration
timeFrame: day 1 and day 20
Other outcomes:
Locations:
city: Huabei
country: China
facility: Zhen Da No.1 Fushu Hos.
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References: