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Clinical Trials/NCT06206538
NCT06206538
Withdrawn
Not Applicable

A Randomized Trial to Explore the Efficacy of Stellate Ganglion Block in Patients With Parkinson's Disease

People's Hospital of Zhengzhou University1 site in 1 countryJanuary 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
People's Hospital of Zhengzhou University
Locations
1
Primary Endpoint
Penetration-Aspiration Scale
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Detailed Description

Dysphagia, or swallowing difficulty, is a common symptom associated with Parkinson's disease. It is characterized by weakened chewing and throat muscles, leading to difficulties in eating, coughing, and a sensation of choking in individuals with Parkinson's disease. 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.

Registry
clinicaltrials.gov
Start Date
January 15, 2024
End Date
April 10, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
People's Hospital of Zhengzhou University
Responsible Party
Principal Investigator
Principal Investigator

Zeng Changhao

Research Director

People's Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

  • Age \>18 years.
  • Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in
  • 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.

Outcomes

Primary Outcomes

Penetration-Aspiration Scale

Time Frame: day 1 and day 20

On the day 1 and day 20, 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

Secondary Outcomes

  • Swallowing duration(day 1 and day 20)
  • Modified Barthel Index(day 1 and day 20)
  • Functional Oral Intake Scale(day 1 and day 20)

Study Sites (1)

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