Efficacy of Stellate Ganglion Block in Children With Autistic Disorder

Not Applicable

Withdrawn

• Conditions: Autistic Disorder
• Interventions: Behavioral: Routine therapy; Procedure: Stellate ganglion block

• Registration Number: NCT06228157
• Lead Sponsor: Zeng Changhao

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Study Start: 2024-02-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-08
• Last Update Posted: 2024-03-12
• Primary Completion: 2024-05-05
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the experimental group	Stellate ganglion block	The study lasts 20d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy. 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 experimental group	Routine therapy	The study lasts 20d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy. 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 control group	Routine therapy	The study lasts 20d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.

Primary Outcome Measures

Name	Time	Method
Childhood Autism Rating Scale	day 1 and day 20	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.

Secondary Outcome Measures

Name	Time	Method
Children's Communication Checklist	day 1 and day 20	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.
Childhood Anxiety Sensitivity Index	day 1 and day 20	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.
Social Interaction Assessment Scale	day 1 and day 20	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.
Children's Depression Inventory	day 1 and day 20	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.

Trial Locations

Locations (1)

Zheng Da yi Yuan Hospital; 🇨🇳 Zhengzhou, Henan, China