Effectiveness of Stellate Ganglion Block in Individuals With Parkinson's Disease

NCT06301724 | Not Yet Recruiting

• 1 other identifier: SGB-PKS
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are: • Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease. Participants will be divided into the the control 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, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Penetration-Aspiration Scale

  Penetration-Aspiration Scale is used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food enter the airway and caused penetration or aspiration during the swallowing process. As the level increases, the severity of dysphagia also increases.The scores rang from 0 to 8

  day 1 and day 10

Secondary Outcomes (2)

• Modified Barthel Index

  day 1 and day 10

• Functional Oral Intake Scale

  day 1 and day 10

Study Arms (2)

Stellate ganglion block

EXPERIMENTAL

the patients were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)

Procedure: Injection; Drug: Lidocaine hydrochloride

Injection

PLACEBO COMPARATOR

the patients were provided with injection, which was with the same procedure of stellate ganglion block but no drugs.

Procedure: Injection

Interventions

Injection PROCEDURE

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.

Injection; Stellate ganglion block

Lidocaine hydrochloride DRUG

the patients 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.

Also known as: Lidocaine

Stellate ganglion block

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 Parkinson's disease developed by the Neurology Branch of the - - Chinese Medical Association in 2006.
• Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
• Stable vital signs, conscious, able to cooperate with assessment and treatment.

You may not qualify if:

• Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
• History of mental diseases or use of antipsychotics.
• Complicated with cognitive impairment or consciousness dysfunction.
• Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.

Sponsors & Collaborators

• Muhammad: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

Injections; Lidocaine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY DIRECTOR

Central Study Contacts

Lavie Ce, Master

CONTACT

15333828388; 17695841016@163.com

Study Design

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

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share