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Completed
NCT05985993
Precise Intervention Technology and Application of Low Intensity TUS on Negative Symptoms of Schizophrenia
Conditions: Negative Symptoms of Schizophrenia
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 78
Sponsor: Shanghai Mental Health Center
Location: Shanghai Mental Health Center Shanghai Shanghai Municipality
Summary
Based on the current background and our previous studies, TUS has been proved that rTUS intervention could induce long-term potentiation like (LTP-like) plasticity and neuromodulate the brain cortex in schizophrenia patients. rTUS over the left dorsolateral prefrontal cortex (DLPFC) can alleviate the negative symptoms in schizophrenia. In this double-blind, randomized, sham-controlled study, the efficacy of different treatment options and mechanisms of low-intensity rTUS on negative symptoms will be investigated.
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.
Source: ClinicalTrials.gov (NCT05985993). StuddyBuddy aggregates publicly available trial information.