Transcranial Sonography and Machine Learning for Schizophrenia Identification

Sponsor
Taizhou Second People's Hospital
Study ID
NCT07604129
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Transcranial Sonography — DIAGNOSTIC_TEST
    Baseline transcranial sonography assessment of brain structural imaging features, including substantia nigra echogenicity, raphe nuclei echogenicity, and third-ventricle width.

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Area Under the ROC Curve of the Final TCS-Clinical Model [ Time Frame: Baseline; analyzed after completion of baseline data collection ]

Central Contacts

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