Efficacy and Mechanisms of Low-intensity Focused Ultrasound on Negative Symptoms in Patients With Schizophrenia
- Conditions
- Negative Symptoms of Schizophrenia
- Interventions
- Device: Low-intensity Focused Ultrasound(LIFUS)
- Registration Number
- NCT04620460
- Lead Sponsor
- Shanghai Mental Health Center
- Brief Summary
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.
- Detailed Description
Firstly, we plan to explore the short-term effects of LIFUS on cortical excitability by detecting the MEP amplitude. 40 patients and relatively well matched healthy-control would be enrolled. After MEP detection and baseline evaluations, the two groups will be treated with one-single intervention on the primary motor cortex. The cognitive function and MEP amplitude will be assessed respectively at the moment, after 15 minutes and 30 minutes. Then, it is a randomized double-blind sham-controlled LIFUS intervention trial in schizophrenia patients. After screening and baseline evaluations, the 40 patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC. The multimodal MRI will be acquired. Clinical symptoms and cognitive function will be assessed respectively at baseline, at the end of fifth treatments and after the end of the treatment.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LIFUS-left DLPFC Low-intensity Focused Ultrasound(LIFUS) 20 patients will be treated with active LIFUS for 3 weeks on the left DLPFC. LIFUS-SHAM Low-intensity Focused Ultrasound(LIFUS) 20 patients will be treated with sham LIFUS for 3 weeks on the left DLPFC.
- Primary Outcome Measures
Name Time Method Clinical Symptoms-SANS baseline and 15 days Change from baseline in the Scale for the Assessment of Negative Symptoms(SANS)
Clinical Symptoms-PANSS baseline and 15 days Change from baseline in Positive and Negative Syndrome Scale(PANSS)
- Secondary Outcome Measures
Name Time Method Cognitive Function baseline, after the fifth treatment and 15 days Change from baseline in the Brief Cognition Test (C-BCT)
Cortex Excitability baseline，the moment after the intervention, after 15 minutes and 30 minutes MEP amplitude
Change of brain neuroimaging baseline, fifth treatment and 15th treatment Brain structure, Resting-state fMRI data, Arterial Spin Labeling(ASL), 1H-MRS in DLPFC are acquired.
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China