Autistic DisorderSGB-guduNCT06228157
Efficacy of Stellate Ganglion Block in Children With Autistic Disorder
A study testing Routine therapy and Stellate ganglion block in people with Autistic Disorder, run by Zeng Changhao at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Routine therapy and Stellate ganglion block
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2024to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed as Autistic Disorder.
- Aged between 6 years old and 12 years old.
- No contraindications to stellate ganglion block.
Who cannot join
- Other significant physical or neurodevelopmental disorders.
- Other significant medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial To Explore the Efficacy of Stellate Ganglion Block in Children With Autistic Disorder
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.
Read the 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.
- Conditions
- Autistic Disorder
- Being tested
- Routine therapy, Stellate ganglion block
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine therapyBehavioural
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.
Stellate ganglion blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Behavioral: Routine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1 and day 20
Secondary outcomes (4)
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.
Measured: day 1 and day 20
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.
Measured: day 1 and day 20
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.
Measured: day 1 and day 20
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.
Measured: day 1 and day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start5 Feb 2024
- Primary completion5 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
Why it stopped: ethical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
- Investigators
- Nieto Luis, Master, Study chair, Site Coordinator of United Medical Group located in Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228157
- Sponsor's protocol ID
- 2024-KY-0119-018
- Acronym
- SGB-gudu
- Status last verified
- Mar 2024
- First submitted
- 19 Jan 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial To Explore the Efficacy of Stellate Ganglion Block in Children With Autistic Disorder
- ClinicalTrials.gov ID
- NCT06228157
- Acronym / sponsor ID
- SGB-gudu / 2024-KY-0119-018
- Conditions
- Autistic Disorder
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: ethical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group | Experimental | Behavioral: Routine therapy, Procedure: Stellate ganglion blockThe 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 | Active comparator | Behavioral: Routine therapyThe study lasts 20d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed as Autistic Disorder.
- Aged between 6 years old and 12 years old.
- No contraindications to stellate ganglion block.
Key exclusion criteria (2 listed)
- Other significant physical or neurodevelopmental disorders.
- Other significant medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine therapyThe study lasts 20d for each patient. During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training. | Behavioural | the control group, the experimental group |
| Stellate ganglion blockBased 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. | Procedure or surgery | the experimental group |
Primary outcome
Childhood Autism Rating Scale
Time frame: 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.
4 secondary outcomes
Children's Communication Checklist
Time frame: day 1 and day 20
Social Interaction Assessment Scale
Time frame: day 1 and day 20
Children's Depression Inventory
Time frame: day 1 and day 20
Childhood Anxiety Sensitivity Index
Time frame: day 1 and day 20
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieto Luis, Master study chair
Site Coordinator of United Medical Group located in Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine therapy and Stellate ganglion block in people with Autistic Disorder, run by Zeng Changhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale (time frame: day 1 and day 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.