Autistic DisorderNCT06319599
Stellate Ganglion Block in Children With Autistic Disorder
A study testing Routine therapy, Stellate ganglion block and Lidocaine hydrochloride in people with Autistic Disorder, run by Copka Sonpashan.
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 4 months to 8 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Routine therapy, Stellate ganglion block and Lidocaine hydrochloride
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 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 4 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed as Autistic Disorder.
- Aged between 4 years old and 8 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
No sites are listed yet.
About this study
Official title: Stellate Ganglion Block in Children With Autistic Disorder: A Randomized Controlled Trial
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, Lidocaine hydrochloride, placebo injection
- 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
During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.
Stellate ganglion blockProcedure or surgery
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.
Lidocaine hydrochlorideDrug
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). Once a day, totally 10 days.
placebo injectionBehavioural
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 |
|---|---|---|
| Routine therapy+Stellate ganglion block | Experimental | The study lasts 10d 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; Drug: Lidocaine hydrochloride |
| Routine therapy+placebo | Placebo comparator | The study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy. Receives: Behavioral: Routine therapy; Behavioral: placebo injection |
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 10
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 10
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 10
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 10
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 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copka Sonpashan
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Copka Sonpashan, Chao Phya Abhaibhubejhr Hospital
- Investigators
- Nieto Luis, Study chair, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319599
- Sponsor's protocol ID
- SGB GUDU
- Status last verified
- Mar 2024
- First submitted
- 10 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block in Children With Autistic Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06319599
- Acronym / sponsor ID
- SGB GUDU
- Conditions
- Autistic Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Copka SonpashanOther government
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Mar 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine therapy+Stellate ganglion block | Experimental | Behavioral: Routine therapy, Procedure: Stellate ganglion block, Drug: Lidocaine hydrochlorideThe study lasts 10d 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) |
| Routine therapy+placebo | Placebo comparator | Behavioral: Routine therapy, Behavioral: placebo injectionThe study lasts 10d for each patient. During the treatment, All the participants are provided with the routine rehabilitation therapy. |
Who may qualify
- Ages
- 4 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed as Autistic Disorder.
- Aged between 4 years old and 8 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 therapyDuring the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training. | Behavioural | Routine therapy+Stellate ganglion block, Routine therapy+placebo |
| Stellate ganglion blockThe 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 | Routine therapy+Stellate ganglion block |
| Lidocaine hydrochlorideBased 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). Once a day, totally 10 days. | Drug | Routine therapy+Stellate ganglion block |
| placebo injectionThe 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. | Behavioural | Routine therapy+placebo |
Primary outcome
Childhood Autism Rating Scale
Time frame: day 1 and day 10
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 10
Social Interaction Assessment Scale
Time frame: day 1 and day 10
Children's Depression Inventory
Time frame: day 1 and day 10
Childhood Anxiety Sensitivity Index
Time frame: day 1 and day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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 study chair
Site Coordinator of United Medical Group
Questions about this trial
What is this clinical trial studying?
A study testing Routine therapy, Stellate ganglion block and Lidocaine hydrochloride in people with Autistic Disorder, run by Copka Sonpashan.
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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lavie Ce (15333828388, zenghongjixx@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale (time frame: day 1 and day 10). 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 20 Mar 2024.