Negative Symptoms of Schizophrenia Clinical Trial
Official title:
Precise Intervention Technology and Application of Low Intensity Transcranial Ultrasound Stimulation (TUS) on Negative Symptoms of Schizophrenia
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.
Status | Not yet recruiting |
Enrollment | 102 |
Est. completion date | December 31, 2025 |
Est. primary completion date | July 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Mental Health Center | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the Scale for Assessment of Negative Symptoms(SANS) | Change from baseline in the Scale for Assessment of Negative Symptoms(SANS) at 4 weeks and 8 weeks. The minimum to maximum value is 0-120. Lower scores mean a better outcome. | baseline, 4 weeks and 8 weeks | |
Primary | Change from baseline in Positive and Negative Syndrome Scale(PANSS) | Change from baseline in Positive and Negative Syndrome Scale(PANSS) at 4 weeks and 8 weeks. The minimum to maximum value is 30-210. Lower scores mean a better outcome. | baseline, 4 weeks and 8 weeks | |
Secondary | Cognitive Function | Change from baseline in MATRICS MCCB | baseline, 4 weeks and 8 weeks | |
Secondary | Change of Multi-modal Brain Neuroimaging in structure | Brain structure data will be acquired. | baseline and 4 weeks | |
Secondary | Change of Multi-modal Brain Neuroimaging in resting- state fMRI | Resting-state fMRI data will be acquired. | baseline and 4 weeks | |
Secondary | Change of Multi-modal Brain Neuroimaging in 1H-MRS | 1H-MRS data will be acquired. | baseline and 4 weeks | |
Secondary | Change of functional near-infrared spectroscopy (fNIRS) | Functional near-infrared spectroscopy (fNIRS), a non-invasive neuroimaging technique that reflects changes in Oxy-Hb and Deoxy-Hb during brain activity, will be measured on left M1 region at baseline to evaluate the neuromodulation effect of TUS on neural activity. | baseline |
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