RECRUITINGINTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form; Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

low-intensity transcranial ultrasound stimulation (TUS)

The rTUS was administered using an immersion-type focused ultrasound transducer (V391-SU, Olympus NDT, Waltham, USA). Low-intensity transcranial ultrasound stimulation on the target. Duration:20 days (workdays for four consecutive weeks).

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China