Status:
RECRUITING
Precise Intervention Technology and Application of Low Intensity TUS on Negative Symptoms of Schizophrenia
Lead Sponsor:
Shanghai Mental Health Center
Conditions:
Negative Symptoms of Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 i...
Detailed Description
Negative symptoms is a core symptom of schizophrenia related to poor functional outcome which remains largely treatment refractory. Prior studies indicated that abnormalities in the prefrontal-tempora...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT05985993
Start Date
December 1 2023
End Date
December 31 2025
Last Update
March 26 2025
Active Locations (1)
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1
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China, 200030