Efficacy of Stellate Ganglion Block in Children With Autistic Disorder

NCT06228157 | Withdrawn DMC

• 1 other identifier: 2024-KY-0119-018
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Children's Communication Checklist

  day 1 and day 20

• Social Interaction Assessment Scale

  day 1 and day 20

• Children's Depression Inventory

  day 1 and day 20

• Childhood Anxiety Sensitivity Index

  day 1 and day 20

Study Arms (2)

the experimental group

EXPERIMENTAL

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)

Behavioral: Routine therapy; Procedure: Stellate ganglion block

the control group

ACTIVE COMPARATOR

The study lasts 20d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy.

Behavioral: Routine therapy

Interventions

Routine therapy BEHAVIORAL

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.

the control group; the experimental group

Stellate ganglion block PROCEDURE

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.

the experimental group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed as Autistic Disorder.
• Aged between 6 years old and 12 years old.
• No contraindications to stellate ganglion block.

You may not qualify if:

• Other significant physical or neurodevelopmental disorders.
• Other significant medical conditions

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zheng Da yi Yuan Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  STUDY CHAIR

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: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: February 5, 2024
• Primary Completion: May 5, 2024
• Study Completion: May 15, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)