Efficacy of Stellate Ganglion Block in Children With Autistic Disorder

Autistic Disorder Clinical Trial

— SGB-gudu  

Official title:

A Randomized Controlled Trial To Explore the Efficacy of Stellate Ganglion Block in Children With Autistic Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06228157
• Other study ID #: 2024-KY-0119-018
• Status: Withdrawn
• Phase: N/A
• Start date: February 5, 2024
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Description:

Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 15, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Diagnosed as Autistic Disorder.

• Aged between 6 years old and 12 years old.

• No contraindications to stellate ganglion block.

Exclusion Criteria:

• Other significant physical or neurodevelopmental disorders.

• Other significant medical conditions

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Behavioral:
• Routine therapy
The study lasts 20d for each patient. During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.

Procedure:
• Stellate ganglion block
Based on the invention above, the patients in the experimental 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.

Locations

Country	Name	City	State
China	Zheng Da yi Yuan Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zeng Changhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Childhood Autism Rating Scale	In the Childhood Autism Rating Scale, the rater observes the behavior of the child in specific situations and assigns scores based on a series of descriptive items. Each item is scored on a range of 0 to 4, with 0 indicating no abnormality and 4 indicating severe abnormality. The rater also considers the overall impression and severity of the child, resulting in a total score. The total score falls between 15 and 60, with higher scores indicating a higher level of autism severity.	day 1 and day 20
Secondary	Children's Communication Checklist	This checklist was to assess language abilities in children aged 2-16. It consists of 70 items divided into eight subscales, including vocabulary, grammar, comprehension, expression, communication, regulation, fluency, and nonverbal communication. Scores range from 0-280, with higher scores indicating better language ability.	day 1 and day 20
Secondary	Social Interaction Assessment Scale	This scale was developed by American psychiatrist Eric Schopler and colleagues to assess social interaction and behavior in children with autism and related disorders. It consists of 29 items divided into three subscales, including social interaction, maladaptive behavior, and language/communication. Scores range from 0-87, with higher scores indicating better social interaction and behavior.	day 1 and day 20
Secondary	Children's Depression Inventory	This inventory was developed by American psychologist Maria Kovacs to assess depression in children aged 7-17. It consists of 27 items covering aspects such as sad mood, self-evaluation, life satisfaction, insomnia, and early morning awakening. Scores range from 0-54, with higher scores indicating greater severity of depression.	day 1 and day 20
Secondary	Childhood Anxiety Sensitivity Index	This index was developed by Australian psychologist Ronald Rapee and colleagues to assess anxiety sensitivity in children aged 8-15. It consists of 18 items covering physical sensations, cognition, and behavior. Scores range from 0-54, with higher scores indicating greater anxiety sensitivity.	day 1 and day 20