Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease

Copka Sonpashan

Status: Not yet enrolling

Conditions: Cerebral Small Vessel Diseases

Treatments: Drug: Lidocaine Hydrochloride; Procedure: Stellate ganglion block; Behavioral: placebo injection; Behavioral: Rehabilitation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06319495

SGB-CSVD

Details and patient eligibility

About

This is a prospective study conducted on patients with Cerebral Small Vessel Disease, 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 Stellate Ganglion Block. 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

This study is conducted for Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease. This is a prospective study conducted on patients with Cerebral Small Vessel Disease, 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 Stellate Ganglion Block. 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: 80 estimated 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.
• 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.
• Neurological blockade contraindications such as bleeding tendency, blocked site infection.
• Unable to successfully finish the assessment of this study.
• 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: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

Rehabilitation therapy+Stellate ganglion block

Experimental group

Description:

The study lasted 10d 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. Based on the invention above, the patients in the observation group were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).

Treatment:

Procedure: Stellate ganglion block

Behavioral: Rehabilitation therapy

Drug: Lidocaine Hydrochloride

Rehabilitation therapy+placebo

Placebo Comparator group

Description:

The study lasted 10d 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.

Treatment:

Behavioral: placebo injection

Behavioral: Rehabilitation therapy