Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease

NCT06176404 | Completed DMC

• 1 other identifier: NXXG-SGB-jiu
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia; Cerebral Small Vessel Diseases; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Penetration-Aspiration Scale

  On the day 1 and day 20, Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased.

  day 1 and day 20

Secondary Outcomes (3)

• Modified Barthel Index

  day 1 and day 20

• Mini-Mental State Examination

  day 1 and day 20

• Swallowing duration

  day 1 and day 20

Study Arms (2)

The comparison group

ACTIVE COMPARATOR

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.

Behavioral: Rehabilitation therapy

The observation group

EXPERIMENTAL

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).

Drug: Stellate ganglion block; Behavioral: Rehabilitation therapy

Interventions

Stellate ganglion block DRUG

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.

Also known as: SGB

The observation group

Rehabilitation therapy BEHAVIORAL

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.

Also known as: Rehabilitation Treatment

The comparison group; The observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zhen Da No.1 Fushu Hos.

Huabei, China

Location

Related Publications (1)

• 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.

  PMID: 39270205 DERIVED

MeSH Terms

Conditions

Deglutition Disorders; Cerebral Small Vessel Diseases; Cognitive Dysfunction

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 19, 2023
• Study Start: February 1, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 31, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)