Clinical trial NCT06206538: Efficacy of Stellate Ganglion Block in Patients With Parkinson's Disease
Official title: A Randomized Trial to Explore the Efficacy of Stellate Ganglion Block in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 20
Secondary outcomes:
measure: Modified Barthel Index
timeFrame: day 1 and day 20
measure: Swallowing duration
timeFrame: day 1 and day 20
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 20
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng Da yi Yuan Hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: PRINCIPAL_INVESTIGATOR
References: