Efficacy of Stellate Ganglion Block in Children With Cerebral Palsy and Dysphagia

A Randomized Controlled Study to Explore The Efficacy of Stellate Ganglion Block in Children With Cerebral Palsy and Dysphagia

The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Study Overview

• Status: Withdrawn
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: routine rehabilitation treatment; Procedure: Stellate ganglion block

Detailed Description

Cerebral palsy is a common non-progressive clinical condition characterized by motor disorders and abnormal postures, which significantly impact the quality of life of affected children. Swallowing dysfunction is a common complication in children with Cerebral palsy , affecting their daily eating and communication skills, and hindering their nutritional development and social interaction. Stellate ganglion block has shown certain efficacy in improving swallowing function in children with Cerebral palsy. However, there is limited research on the effects of stellate ganglion block treatment on swallowing dysfunction in children with Cerebral palsy. Therefore, this study aims to explore this topic and provide scientific evidence for its clinical application.

The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:

• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Zheng da yi fu yuan hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
• age between 4 to 7 years;
• diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;

Exclusion Criteria:

• with dysphagia caused by other diseases or factors;
• with progressive neurological disease or degenerative neurological disease;
• with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms;
• with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
• with poor compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the experimental group; All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.The experimental group was given Stellate Ganglion Block.	Behavioral: routine rehabilitation treatment; All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time. Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time. Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time. Direct feeding training: with powdered milk, once a day, 5 days a week.; Procedure: Stellate ganglion block; The patients were provided with Stellate ganglion block , using 0.5ml 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.
Active Comparator: the control group; All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.	Behavioral: routine rehabilitation treatment; All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time. Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time. Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time. Direct feeding training: with powdered milk, once a day, 5 days a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1 and day 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swallowing duration	The time duration that the patient swallowed the contrast agent under Videofluoroscopic Swallowing Study the is recorded.Unit: seconds.	day 1 and day 20
Functional Oral Intake Scale	During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, the increasing of scores indicating a progressive improvement in the patient's oral intake ability.	day 1 and day 20

Collaborators and Investigators

• Sponsor: Zeng Changhao
• Collaborators: The First Affiliated Hospital of Zhengzhou University
• Investigators: Principal Investigator: Nieto Luis, Master, Site Coordinator of United Medical Group located in Miami

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): April 25, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2023-KY-1031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No