Using low-intensity ultrasound to treat negative symptoms of schizophrenia

Precise Intervention Technology and Application of Low Intensity Transcranial Ultrasound Stimulation (TUS) on Negative Symptoms of Schizophrenia

This study is testing whether low-intensity ultrasound can help people with schizophrenia who have trouble with negative symptoms feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05985993 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of low-intensity transcranial ultrasound stimulation (TUS) on the negative symptoms of schizophrenia, which are often resistant to treatment. It employs a double-blind, randomized, sham-controlled design to assess the efficacy of TUS applied to the left dorsolateral prefrontal cortex (DLPFC) and potentially the right superior temporal gyrus (STG). Participants will be schizophrenia inpatients with predominant negative symptoms, who will be randomly assigned to receive either active treatment or sham stimulation. The study aims to explore the underlying neural mechanisms and optimize treatment strategies through neuropsychological assessments and advanced imaging techniques.

Who should consider this trial

Good fit: Ideal candidates are right-handed individuals aged 18-50 diagnosed with schizophrenia or schizoaffective disorder, experiencing moderate to severe negative symptoms.

Not a fit: Patients with current or past neurological illnesses, severe physical diseases, or those who are uncooperative or at risk of harm may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management of negative symptoms in schizophrenia, enhancing patients' functional outcomes.

How similar studies have performed: While the use of transcranial ultrasound stimulation is a relatively novel approach, prior studies have shown promise in neuromodulation techniques for treating various psychiatric conditions.

Eligibility criteria

Inclusion Criteria:

* Meet the DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder;
* Age18-50, right-handed, Han nationality;
* Score of at least 1 item from N1 to N7 in PANSS is ≥4 (moderate or above);
* Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more;
* Written informed consent;

Exclusion Criteria:

* Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnant or lactation;
* Uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.;
* History of MECT or other physical therapy within 6 months;
* History of epilepsy, or epileptic waves on the baseline EEG;
* Ruled out share antiepileptic drugs, carbamazepine, valproic acid salt) or larger doses of benzodiazepines drugs (\> 10 mg/day, diazepam clonazepam 2 mg/day, 1 mg/day, alprazolam lorazepam 2 mg/day, midazolam 10 mg/day, 20 mg/day, Mr Shah diazepam triazolam 0.5 mg/day), avoid the use of chlorine drug, (in principle, to avoid the use of antiepileptic drugs and clonazepam;Other antipsychotic drugs, if necessary, remain unchanged during the course of treatment;
* Contraindications to TUS and MRI are present.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Dengtang LIU

Conditions Negative Symptoms of Schizophrenia; Schizophrenia; Negative Symptoms; Transcranial Ultrasound Stimulation