Cerebral PalsyNCT06848959
Development and Application of a Diagnosis and Treatment System for Children's Brain Diseases Based on Knowledge Graphs and Large Models
An observational study of Cerebral Palsy and Mental Retardation, run by Yun Liu,PhD at 1 site in China.
Trial summary
Using the knowledge graph and big model technology of combining Chinese and Western medicine we construct a popularization and prevention system for childhood encephalopathy an assisted decision-making system for childhood encephalopathy and a follow-up tracking question and answer system for childhood encephalopathy… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy, Mental Retardation, Tourette's Syndrome
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Childhood encephalopathy
Who may be able to join
- 1. meet diagnostic criteria for CP ID TD ADHD ASD; 2. gender is not limited;
Who cannot join
- 1. CP ID TD ASD due to chorea hepatomegaly hearing abnormality and pharmacogenetic factors;
- 2. Children with other major mental illnesses (e.g. schizophrenia) or organic diseases (e.g. congenital heart disease);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing
Dong Chen Dr., +86 134 0587 1656, 648728749@qq.com
About this study
Official title: Jiangsu Provincial Hospital of Traditional Chinese Medicine
Using the knowledge graph and big model technology of combining Chinese and Western medicine we construct a popularization and prevention system for childhood encephalopathy an assisted decision-making system for childhood encephalopathy and a follow-up tracking question and answer system for childhood encephalopathy patients.
- Conditions
- Cerebral Palsy, Mental Retardation, Tourette's Syndrome, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorders
- Being tested
- No intervention
- Medical subject headings
- Cerebral Palsy, Intellectual Disability, Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Pediatric Encephalopathy Science and Prevention Decision Aid Follow-Up Q\&A
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Autism Rating Scale
The total score ranges from 15 to 60, with the higher the score the worse the symptoms are
Measured: 4 mouths
meridian and acupointological features
After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".
Measured: 4 mouths
Yale Global Tic Severity Scale
It has a score range of 0-100, with higher scores representing more severe symptoms.
Measured: 4 mouths
Gross Motor Function Assessment Scale (GMFM)-88
GMFM-88 scores range from 0-264, with higher scores being better.
Measured: 4 mouths
Autism Behavior Checklist
It has a score range of 0-174, with higher scores representing more severe symptoms.
Measured: 4 mouths
acupuncture point status
After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".
Measured: 4 mouths
Tongue texture
After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".
Measured: 4 mouths
Wechsler intelligence scale (WIS)
FIQ = 100: Indicates that the individual has an average level of intelligence. FIQ > 100: Indicates an above average level of intelligence. FIQ < 100: Indicates a below average level of intelligence.
Measured: 4 mouths
Resting heart rate
Measured: 4 mouths
blood pressure (systolic, diastolic) after 10 minutes of rest
Measured: 4 mouths
Conners Rating Scales
Scores are converted to standardized T-scores for comparison with the mean of the peer group. T-scores above 65 are usually considered clinically significant.
Measured: 4 mouths
tongue coating, pulse
After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".
Measured: 4 mouths
respiratory rate
Measured: 4 mouths
Body temperature
Measured: 4 mouths
Secondary outcomes (4)
Saliva
Destruction after use. Metabolomics after sample collection.
Measured: 4 mouths
blood
Destruction after use. Metabolomics after sample collection.
Measured: 4 mouths
Urine
Destruction after use. Metabolomics after sample collection.
Measured: 4 mouths
Faeces
Destruction after use. Metabolomics after sample collection.
Measured: 4 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jan 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Yun Liu,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun Liu,PhD, Affiliated Hospital of Nanjing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848959
- Sponsor's protocol ID
- HospitalNanjingU
- Other IDs
- Nanjing Science and Technology
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jiangsu Provincial Hospital of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT06848959
- Acronym / sponsor ID
- HospitalNanjingU
- Conditions
- Cerebral Palsy, Mental Retardation, Tourette's Syndrome, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yun Liu,PhDUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Feb 2025 (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.
Using the knowledge graph and big model technology of combining Chinese and Western medicine we construct a popularization and prevention system for childhood encephalopathy an assisted decision-making system for childhood encephalopathy and a follow-up tracking question and answer system for childhood encephalopathy patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Childhood encephalopathy
Key inclusion criteria (1 listed)
- 1. meet diagnostic criteria for CP ID TD ADHD ASD; 2. gender is not limited;
Key exclusion criteria (2 listed)
- 1. CP ID TD ASD due to chorea hepatomegaly hearing abnormality and pharmacogenetic factors;
- 2. Children with other major mental illnesses (e.g. schizophrenia) or organic diseases (e.g. congenital heart disease);
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 |
|---|---|---|
| No interventionPediatric Encephalopathy Science and Prevention Decision Aid Follow-Up Q\&A | Other | – |
Primary outcome
Childhood Autism Rating Scale
Time frame: 4 mouths
The total score ranges from 15 to 60, with the higher the score the worse the symptoms are
meridian and acupointological features
Time frame: 4 mouths
After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".
Yale Global Tic Severity Scale
Time frame: 4 mouths
It has a score range of 0-100, with higher scores representing more severe symptoms.
Gross Motor Function Assessment Scale (GMFM)-88
Time frame: 4 mouths
GMFM-88 scores range from 0-264, with higher scores being better.
Autism Behavior Checklist
Time frame: 4 mouths
It has a score range of 0-174, with higher scores representing more severe symptoms.
acupuncture point status
Time frame: 4 mouths
After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".
Tongue texture
Time frame: 4 mouths
After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".
Wechsler intelligence scale (WIS)
Time frame: 4 mouths
FIQ = 100: Indicates that the individual has an average level of intelligence. FIQ > 100: Indicates an above average level of intelligence. FIQ < 100: Indicates a below average level of intelligence.
Resting heart rate
Time frame: 4 mouths
blood pressure (systolic, diastolic) after 10 minutes of rest
Time frame: 4 mouths
Conners Rating Scales
Time frame: 4 mouths
Scores are converted to standardized T-scores for comparison with the mean of the peer group. T-scores above 65 are usually considered clinically significant.
tongue coating, pulse
Time frame: 4 mouths
After obtaining the information through diagnosis by a professional Chinese medicine practitioner, assist in the diagnosis of clinical subtypes of children according to the corresponding typology of "Pediatrics of Chinese Medicine".
respiratory rate
Time frame: 4 mouths
Body temperature
Time frame: 4 mouths
4 secondary outcomes
Saliva
Time frame: 4 mouths
blood
Time frame: 4 mouths
Urine
Time frame: 4 mouths
Faeces
Time frame: 4 mouths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Mental Retardation, run by Yun Liu,PhD 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 1 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: looking for participants now, as of the sponsor's last update on 27 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yun Liu PhD (+86 13023876996, 20200413@njucm.edu.cn), 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: 4 mouths). The study lists 14 primary outcomes in all. 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 27 Feb 2025.