Precise Intervention Technology and Application of Low Intensity TUS on Negative Symptoms of Schizophrenia

Launched by SHANGHAI MENTAL HEALTH CENTER · Aug 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for the negative symptoms of schizophrenia, which can include feelings of apathy, lack of motivation, and social withdrawal. The trial is testing a method called low-intensity transcranial ultrasound stimulation (TUS) applied to a specific part of the brain known as the dorsolateral prefrontal cortex. Researchers want to see if this treatment can help improve these negative symptoms in patients who have been diagnosed with schizophrenia.

To be eligible for the trial, participants must be between 18 and 50 years old, right-handed, and meet certain criteria for schizophrenia. They should have been stable on medication for at least four weeks before joining the study. People with certain health conditions, a history of severe mental illness, or those currently taking specific medications may not be able to participate. If someone joins the trial, they can expect to receive either the active treatment or a placebo (a treatment that does not contain active ingredients) and will help researchers understand how effective this new method can be. Your participation will contribute to important research that could lead to better treatments for people with schizophrenia.

Gender

ALL

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.