Transcranial Sonography: Baseline transcranial sonography assessment of brain structural imaging features, including substantia nigra echogenicity, raphe nuclei echogenicity, and third-ventricle width.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
Schizophrenia group:
1. Adults aged 18 to 65 years.
2. Diagnosis of schizophrenia according to ICD-10 criteria by a psychiatrist.
3. Able to complete clinical assessment and transcranial sonography examination.
4. No other severe physical disease, neurological disease, or major psychiatric disorder.
5. Written informed consent provided by the participant or legally authorized representative.
Healthy control group:
1. Adults aged 18 to 65 years.
2. No personal history of psychiatric disorders.
3. No family history of psychiatric disorders.
4. No severe physical disease, neurological disease, or major psychiatric disorder.
5. Basic demographic characteristics matched as far as possible to the schizophrenia group.
6. Able to complete clinical assessment and transcranial sonography examination.
7. Written informed consent provided by the participant or legally authorized representative.
Exclusion Criteria:
1. Severe physical disease or neurological disease.
2. History of drug or alcohol abuse.
3. Inability to complete clinical assessment or transcranial sonography examination.
4. Inadequate temporal acoustic window or poor image quality preventing valid transcranial sonography measurements.
5. Acute or clinically unstable state that prevents completion of study procedures.
6. Comorbid major psychiatric disorder, such as major depressive disorder.
7. Refusal or withdrawal of informed consent.
Primary outcome measure(s)
Area Under the ROC Curve of the Final TCS-Clinical Model — Baseline; analyzed after completion of baseline data collection 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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