Optic

ID

NCT06319495

Name

SGB-CSVD

Description

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.

Trial arms

Trial start

2024-03-01

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Not yet recruiting

Treatment

Rehabilitation therapy

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 was provided.

Arms:

Rehabilitation therapy+Stellate ganglion block, Rehabilitation therapy+placebo

Stellate ganglion block

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). The percutaneous approach via the paratracheal route was used for Stellate ganglion block. 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.

Arms:

Rehabilitation therapy+Stellate ganglion block

Lidocaine Hydrochloride

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). The percutaneous approach via the paratracheal route was used for Stellate ganglion block. 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.

Arms:

Rehabilitation therapy+Stellate ganglion block

placebo injection

1 milliliter of normal saline will be used for injection. The percutaneous approach via the paratracheal route was used for Stellate ganglion block. 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.

Arms:

Rehabilitation therapy+placebo

Size

80

Primary endpoint

Penetration-Aspiration Scale

day 1 and day 10

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-03-20

Organization

Copka Sonpashan

Product

Lidocaine

Indication

Cerebral Small Vessel Diseases

A Randomized Controlled Trial For Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease