NCT06206538

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

January 4, 2024

Last Update Submit

March 2, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Penetration-Aspiration Scale

    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

    day 1 and day 20

Secondary Outcomes (3)

  • Modified Barthel Index

    day 1 and day 20

  • Swallowing duration

    day 1 and day 20

  • Functional Oral Intake Scale

    day 1 and day 20

Study Arms (2)

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

Procedure: Stellate ganglion blockBehavioral: Rehabilitation therapy

The control 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

Interventions

Stellate ganglion blockPROCEDURE

Based on the invention above, the patients in the observation group 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.

The observation group
Rehabilitation therapyBEHAVIORAL

he 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 control groupThe observation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zheng Da yi Yuan Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nieto Luis, Master

    Site Coordinator of United Medical Group located in Miami

    PRINCIPAL INVESTIGATOR
0

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
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 16, 2024

Study Start

January 15, 2024

Primary Completion

April 1, 2024

Study Completion

April 10, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)