Precise Intervention Technology and Application of Low Intensity Transcranial Ultrasound Stimulation (TUS) on Negative Symptoms of Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change from baseline in the Brief Negative Symptom Scale (BNSS)
研究概览
简要总结
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.
详细描述
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-temporal circuit and glutamate/GABA imbalances may be the root causes of negative symptoms. Transcranial ultrasound stimulation (TUS), an emerging non-invasive neuromodulation technique, can modulate neuroplasticity in the prefrontal and temporal cortex. 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. Schizophrenia inpatients with predominant negative symptoms will be recruited and randomly allocated into single-target group (left DLPFC), both-target group (both left DLPFC and right STG) or sham group in ratio of 1:1:1. This study aims to determine the efficacy of TUS and to reveal its underlying neural mechanism. MEPs, TEPs ,multi-modal MRI and rs-EEG will be detected. Neuropsychological assessments will also be conducted to develop the optimized treatment strategy. The study points to a novel and promising therapeutic neuromodulation approach that may improve the functional outcome of schizophrenia, which has been the main cause of mental disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
single-target group (left DLPFC)
27 eligible patients will be treated with active TUS for 4 weeks on the left DLPFC
干预措施: low-intensity transcranial ultrasound stimulation (TUS) (Device)
both-target group (both left DLPFC and right STG)
27 eligible patients will be treated with active TUS for 4 weeks on the both left DLPFC and right STG
干预措施: low-intensity transcranial ultrasound stimulation (TUS) (Device)
sham group
27 eligible patients will be treated with sham TUS for 4 weeks on the left DLPFC and right STG, respectively.
干预措施: low-intensity transcranial ultrasound stimulation (TUS) (Device)
结局指标
主要结局
Change from baseline in the Brief Negative Symptom Scale (BNSS)
时间窗: baseline, 4 weeks and 8 weeks
Change from baseline in the Brief Negative Symptom Scale (BNSS) at 4 weeks and 8 weeks. The minimum to maximum value is 0-78. Lower scores mean a better outcome.
Change from baseline in the Scale for Assessment of Negative Symptoms(SANS)
时间窗: baseline, 4 weeks and 8 weeks
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.
Change from baseline in Positive and Negative Syndrome Scale(PANSS)
时间窗: baseline, 4 weeks and 8 weeks
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.
次要结局
- Change of cognitive Function(baseline, 4 weeks and 8 weeks)
- Change of Multi-modal Brain Neuroimaging in structure(baseline and 4 weeks)
- Change of Multi-modal Brain Neuroimaging in resting- state fMRI(baseline and 4 weeks)
- Change of Multi-modal Brain Neuroimaging in 1H-MRS(baseline and 4 weeks)
- Change of EEG microstates(baseline and 4 weeks)
- Change of TEPs(baseline, Day1, and 4weeks)