jRCTs032240756招募中不适用
A trial on the effect of photobiomodulation on cognitive impairment in schizophrenia
未提供0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 主要终点
- Adverse events presence and frequency
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 70age old not(—)
- 性别
- All
入选标准
- •(1) Meeting DSM-5 criteria for schizophrenia
- •(2) Being 18 through 70 years old
- •(3) Being able to understand the objective and content of the study and provide consent to participate
- •(4) Scoring less than 0.5SD on the Rey Auditory Verbal Learning Test and Digit Symbol cordings at baseline
排除标准
- •(1) Current or past history of traumatic brain injury, severe brain lesion or epilepsy
- •(2) Alcohol or substance disorder within the past 12 months
- •(3) Diagnosed with Intellectual Disability
- •(4) Contraindicated to electroconvulsive therapy and clinically contraindicated by tPBM (e.g., history of brain traumatic injury)
- •(5) Treated with cognitive rehabilitation therapy within the past one month
- •(6) Being judged inappropriate to participate for other reasons
结局指标
主要结局
Adverse events presence and frequency
时间窗: baseline, 1 week, 3 months, and 6 months
Confirmation of the presence and frequency of adverse events (based on MedDRA Version 26.0 and the Common Terminology Criteria for Adverse Events)
次要结局
- Change in MADRS score(baseline, 3 months, and 6 months)
- Change in SLOF score(baseline, 3 months, and 6 months)
- Change in SCoRS score(baseline, 3 months, and 6 months)
- Change in SANS score(baseline, 3 months, and 6 months)
- Change in SAPS score(baseline, 3 months, and 6 months)
- Change in SWLS score(baseline, 3 months, and 6 months)
- Change in the amplitude of mismatch negativity(MMN)(baseline, 3 months, and 6 months)
研究者
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