Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome

Babujinaya Cela

Status: Not yet enrolling

Conditions: Parkinson's Syndrome

Treatments: Behavioral: Comprehensive rehabilitation; Procedure: Placebo injection; Procedure: Stellate ganglion block; Drug: Lidocaine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06370195

SGB-Liuxian

Details and patient eligibility

About

This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.

Full description

Palliation of dysphagia in patients with Parkinson's syndrome continues to be a challenge.

This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Comprehensive rehabilitation+Stellate ganglion block

Experimental group

Description:

Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.

Treatment:

Drug: Lidocaine hydrochloride

Procedure: Stellate ganglion block

Behavioral: Comprehensive rehabilitation

Comparator: Comprehensive rehabilitation+placebo

Placebo Comparator group

Description:

Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.

Treatment:

Procedure: Placebo injection

Behavioral: Comprehensive rehabilitation