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Clinical efficacy and neural mechanism of transcranial focused ultrasound stimulation in the treatment of negative symptoms in patients with schizophrenia

Clinical efficacy and neural mechanism of transcranial focused ultrasound stimulation in the treatment of negative symptoms in patients with schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096646
Enrollment
Unknown
Registered
2025-01-27
Start date
2025-02-08
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Transcranial Focused Ultrasound True Stimulation Group:Transcranial focused ultrasound true stimulation Ultrasound Stimulation Intensity: Connect the ultrasonic transducer to the stimulation device, a
T1 = 200µs
T2 = 1 ms
T3 = 100 ms
T4 = 10 s. Equivalent to DC = 20%
PRF = 1000 Hz. The intensity was set at 50% with ISPTA = 333 mW/cm^2, and at the same time, ultrasound stimulation using these parameters has been shown to have no long-term damage to cortical structu
Transcranial focused ultrasound sham stimulation group:Transcranial focused ultrasound false stimulation

Sponsors

Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1.Meets the diagnostic criteria for schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5); 2.The patient's physical examination, medical history, vital signs, blood and urine routine, liver and kidney function, electrolytes, electrocardiogram, electroencephalogram and other indicators are normal; 3.Age above 18 years old and below 55 years old, gender not limited; 4.Positive and Negative Syndrome Scale (PANSS) score >= 60; 5.After fully understanding the safety of transcranial focused ultrasound, I am willing to actively cooperate with treatment and obtain informed consent from myself and my family members.

Exclusion criteria

Exclusion criteria: 1.After conducting psychiatric interviews, it was discovered that there are other mental disorders present; 2.The laboratory examination of patients with metal or electronic devices, such as intracranial metal foreign bodies, cochlear implants, pacemakers, and stents, may reveal situations that may affect the efficacy or safety of the subjects; 3.There is a risk of epileptic seizures, with a history of cranial disease, head trauma, alcohol abuse, abnormal electroencephalogram, MRI evidence of abnormal brain structure, or a family history of epilepsy; 4.Pregnant or planning to become pregnant during the trial period; 5.Received ECT treatment within 2 months prior to enrollment.

Design outcomes

Primary

MeasureTime frame
RBANS Cognitive Scale Assessment ;PANSS Scale Evaluation Score;TMS-EEG data;Changes in nerve structure;

Secondary

MeasureTime frame
Cerebral hemodynamic indicators;

Countries

China

Contacts

Public ContactWenhao Zhuang

Affiliated Kangning Hospital of Ningbo University

295265433@qq.com+86 574 26302520

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026