跳至主要内容
临床试验/jRCTs032240756
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

发起方
未提供

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