Optimizing Treatment Protocol of High Frequency Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits and Negative Symptoms in Schizophrenia: an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Assessment of Negative Symptoms(SANS) Post Treatment
研究概览
简要总结
Negative symptoms and cognition decline are major challenges in clinical management of schizophrenia. Dorsomedial prefrontal cortex (DLPFC) has been highly involved in the mechanisms of negative symptoms and cognitive symptoms of schizophrenia. However, the effect of repetitive transcranial magnetic stimulation (rTMS) over left or bilateral DLPFC has not yet been well studied. The aim of this study is to describe how the effectiveness of rTMS over different targets for cognitive deficits and negative symptoms in schizophrenia will be evaluated. The study will provide evidence to determine whether a bilateral DLPFC rTMS and is more effective than a left DLPFC rTMS alone to optimize treatment protocol in schizophrenia.
详细描述
The study will be a randomized, double-blind trial comparing active rTMS over bilateral DLPFC vs. active rTMS over left DLPFC vs. sham rTMS delivered over DLPFC an 4-week treatment period. After assessment and inclusion into the study, participants will be randomized to receive up to 20 sessions of either active rTMS over left DLPFC or bilateral DLPFC or placebo treatments.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met the Diagnostic and Statistical Manual of Mental Disorders, Five Edition (DSM-V) diagnostic criteria for schizophrenia and the diagnosis was verified by an experienced psychiatrist based on the Mini-International Neuropsychiatric Interview (MINI) 7.0 .
- •Age between 18 and
- •Patients with prominently negative symptoms, which was defined as: PANSS negative subscore≥15 points and one of items N1-N7 scoring≥
- •All patients were in stable clinical conditions (reduction rate of PANSS score<10% within 4 weeks), stable antipsychotic treatment for at least 4 weeks, and able to provide informed consent.
排除标准
- •Any contraindication for rTMS (e.g., intracranial metal, pacemakers, cochlear and intracranial hypertension).
- •Unstable clinical condition (e.g., being aggressive and uncooperative).
- •Current substance abuse.
- •Any other psychiatric diagnosis.
- •Significant medical condition including neurological disease, severe cardiovascular, hepatic, renal diseases.
- •Previous treatment with modified electric convulsive therapy (MECT) within 3 months before enrollment.
研究组 & 干预措施
Active rTMS over bilateral dorsolateral prefrontal cortex
Active rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
干预措施: Bilateral Active Repetitive transcranial magnetic stimulation (rTMS) (Device)
Sham rTMS over bilateral dorsolateral prefrontal cortex
Sham rTMS over bilateral dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
干预措施: Sham rTMS over bilateral dorsolateral prefrontal cortex (Device)
Active rTMS over left dorsolateral prefrontal cortex
Active rTMS over left dorsolateral prefrontal cortex and sham rTMS over right dorsolateral prefrontal cortex. Participants will receive up to 20 rTMS sessions within the 4-week treatment period.
干预措施: Left Active Repetitive transcranial magnetic stimulation (rTMS) (Device)
结局指标
主要结局
Mean Change From Baseline in Assessment of Negative Symptoms(SANS) Post Treatment
时间窗: Baseline and 4 weeks
The Assessment of Negative Symptoms(SANS) is a standardized assessment utilizing a 6-point scale with which the clinician rates the degree to which the severity of the subject's negative symptoms. It consists of 19 items assessing five symptoms of the negative dimension: Affect flattening, alogia, avolition-apathy, anhedonia-asociality, and poor attention.
Mean Change From Baseline in MATRICS Consensus Cognitive Battery Post Treatment
时间窗: Baseline and 4 weeks
The MATRICS Consensus Cognitive Batteryis a standardized rating tool to assess the severity of the subject's cognitive symptoms, which consisted of seven domains and the total score: speed of processing, attention/vigilance, working memory, visual learning, verbal learning, reasoning/problem solving, and social cognition.
次要结局
- Mean Change From Baseline in Positive and Negative Syndrome Scale(PANSS)-Negative Symptoms Subscale Post Treatment(Baseline and 4 weeks)
- Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) Post Treatment(Baseline and 4 weeks)
- Mean Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Post Treatment(Baseline and 4 weeks)