Negative Symptoms of Schizophrenia Clinical Trial
Official title:
Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia
Based on our research background, we hypothesize that LIFUS has neuromodulation effects on brain cortex and the active LIFUS on left-DLPFC would improve negative symptoms in schizophrenia patients. It would firstly verify the safety of LIFUS on human as well. The multimodal MRI will be contributed to investigate the possible mechanism of negative symptoms.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 31, 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | - Inclusion Criteria (patients): 1. Meet the DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder; 2. Age18-50, right-handed, Han nationality; 3. the score of at least 1 item from N1 to N7 is =4 (moderate or above); 4. Be in a stable condition, received second-generation antipsychotics for at least 4 weeks or more; 5. Written informed consent; - Exclusion Criteria (patients): 1. Current or past neurological illness, severe physical diseases, substance abuse or alcohol dependence, mental retardation, pregnant or lactation; 2. Uncooperative or risky patients with high excitement, stupor, disorder of words and deeds, negative suicide, etc.; 3. A history of MECT or other physical therapy within 6 months; 4. A history of epilepsy, or epileptic waves on the baseline EEG; 5. 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; 6. Contraindications to LIFUS 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 | Clinical Symptoms-PANSS | Change from baseline in Positive and Negative Syndrome Scale(PANSS) | baseline and 15 days | |
Primary | Clinical Symptoms-SANS | Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS) | baseline and 15 days | |
Secondary | Cognitive Function | Change from baseline in the Brief Cognition Test (C-BCT) | baseline, after the fifth treatment and 15 days | |
Secondary | Change of brain neuroimaging | Brain structure, Resting-state fMRI data, Arterial Spin Labeling(ASL), 1H-MRS in DLPFC are acquired. | baseline, fifth treatment and 15th treatment | |
Secondary | Cortex Excitability | MEP amplitude | baseline,the moment after the intervention, after 15 minutes and 30 minutes |
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