Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease

Zeng Changhao

Status: Completed

Conditions: Dysphagia; Cognitive Impairment; Cerebral Small Vessel Diseases

Treatments: Drug: Stellate ganglion block; Behavioral: Rehabilitation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06176404

NXXG-SGB-jiu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

The comparison group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Rehabilitation therapy

The observation group

Experimental group

Description:

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).

Treatment:

Behavioral: Rehabilitation therapy

Drug: Stellate ganglion block