Transcranial Sonography and Machine Learning for Schizophrenia Identification
TCS-ML-SZ
Development and Validation of an Early Prediction Model for Schizophrenia Integrating Transcranial Sonography Structural Imaging and Machine Learning
2 other identifiers
observational
200
1 country
1
Brief Summary
Schizophrenia is a serious mental illness. Doctors usually diagnose schizophrenia by talking with patients, reviewing symptoms, and using clinical assessment. In early or less typical cases, diagnosis may be difficult. This study will look at whether brain ultrasound information can help doctors identify features related to schizophrenia. The ultrasound scan used in this study is called transcranial sonography. It is a non-invasive scan that uses sound waves to look at brain structures through natural thin areas of the skull. The study will include adults with schizophrenia and adults without a personal or family history of mental disorders. All participants will have a transcranial sonography scan and provide basic clinical information. The researchers will measure brain ultrasound features, including the substantia nigra, raphe nuclei, and third ventricle, and will combine these features with clinical information. The main question is whether a computer model using ultrasound and clinical information can help distinguish adults with schizophrenia from adults without schizophrenia. The model is intended only as a research tool and possible future aid for doctors. It will not replace diagnosis by a psychiatrist and will not change the participant's usual medical care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
Study Completion
Last participant's last visit for all outcomes
December 31, 2027
May 22, 2026
May 1, 2026
1.5 years
May 17, 2026
May 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the ROC Curve of the Final TCS-Clinical Model
The area under the receiver operating characteristic curve will be used to assess the ability of the final machine-learning model, based on transcranial sonography and clinical variables, to distinguish participants with ICD-10 schizophrenia from healthy controls. The reference standard will be clinical diagnosis according to ICD-10 criteria.
Baseline; analyzed after completion of baseline data collection
Secondary Outcomes (3)
Sensitivity and Specificity of the Final TCS-Clinical Model
Baseline; analyzed after completion of baseline data collection
Other Classification Performance Metrics of the Final Model
Baseline; analyzed after completion of baseline data collection
Calibration Performance of the Final TCS-Clinical Model
Baseline; analyzed after completion of baseline data collection
Study Arms (2)
Schizophrenia Group
Adults aged 18 to 65 years with schizophrenia diagnosed according to ICD-10 criteria. Participants will undergo baseline transcranial sonography assessment and clinical data collection.
Healthy Control Group
Adults aged 18 to 65 years without a personal or family history of psychiatric disorders and matched as far as possible to the schizophrenia group by basic demographic characteristics. Participants will undergo baseline transcranial sonography assessment and clinical data collection.
Interventions
Baseline transcranial sonography assessment of brain structural imaging features, including substantia nigra echogenicity, raphe nuclei echogenicity, and third-ventricle width.
Eligibility Criteria
Adults aged 18 to 65 years will be recruited from Taizhou Second People's Hospital and related recruitment channels. The study population will include participants with schizophrenia diagnosed according to ICD-10 criteria and healthy control participants without a personal or family history of psychiatric disorders. Healthy controls will be matched as far as possible to the schizophrenia group by basic demographic characteristics. All participants will undergo baseline transcranial sonography assessment and clinical data collection.
You may qualify if:
- Schizophrenia group:
- Adults aged 18 to 65 years.
- Diagnosis of schizophrenia according to ICD-10 criteria by a psychiatrist.
- Able to complete clinical assessment and transcranial sonography examination.
- No other severe physical disease, neurological disease, or major psychiatric disorder.
- Written informed consent provided by the participant or legally authorized representative.
- Healthy control group:
- Adults aged 18 to 65 years.
- No personal history of psychiatric disorders.
- No family history of psychiatric disorders.
- No severe physical disease, neurological disease, or major psychiatric disorder.
- Basic demographic characteristics matched as far as possible to the schizophrenia group.
- Able to complete clinical assessment and transcranial sonography examination.
- Written informed consent provided by the participant or legally authorized representative.
You may not qualify if:
- Severe physical disease or neurological disease.
- History of drug or alcohol abuse.
- Inability to complete clinical assessment or transcranial sonography examination.
- Inadequate temporal acoustic window or poor image quality preventing valid transcranial sonography measurements.
- Acute or clinically unstable state that prevents completion of study procedures.
- Comorbid major psychiatric disorder, such as major depressive disorder.
- Refusal or withdrawal of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taizhou Second People's Hospital
Taizhou, Zhejiang, 317200, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 17, 2026
First Posted
May 22, 2026
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
The individual participant data generated or analyzed during this study will not be publicly shared because of participant privacy, the sensitive nature of psychiatric clinical data, and restrictions in the ethics approval and informed consent. Aggregated results will be reported in the published article.