A Study of Cognitive Enhancement of Transcranial Direct Current Stimulation on Working Memory in Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Visual-spatial working memory span measured by Corsi Block-Tapping task
研究概览
简要总结
The investigators plan to investigate the effect of enhancement on working memory (WM) in patients of chronic schizophrenia and determine the predictive factors of effective treatment.
详细描述
Schizophrenia is a chronic and disabling disease with a prevalence of 0.5%~1.5% in the general population. It's estimated 98% of patients with schizophrenia exhibit variable degrees of cognitive deficits which have been well established to be predictive of patient functioning. A number of treatments had been developed for cognitive enhancement in patients with schizophrenia, nevertheless none of them showed satisfying results.
Transcranial direct current stimulation (tDCS) is a safe and convenient treatment which has showed some evidence of beneficial effects on working memory (WM) in both healthy and neuropsychiatric populations. However, studies of tDCS for cognitive enhancement in patients with schizophrenia are still quiet limited. The results of our previous studies in healthy participants and patients with diabetic polyneuropathy suggest that the anodal tDCS over right dorsolateral prefrontal cortex (DLPFC) improved spatial WM capacity, particularly when task difficulty demands more complex mental manipulations and for the low-performing patients in baseline assessments. Thus, we hypothesize that in the baseline the more severe the patients' cognitive deficit are, the greater their WM capacity improvement would be after applying the anodal Tdcs over right DLPFC.
The investigators plan to recruit 40 patients with chronic schizophrenia. First, the investigators will collect baseline characteristics including disease severity, cognitive deficits and brain connectivity. Then the investigators will adopt a sham-active crossover design for tDCS treatment with the order of the two sessions (sham and active) counterbalanced across participants. The investigators will perform pre- tDCS and post- tDCS assessments of their spatial WM and verbal WM as well as statistical analyses to see if the effect of cognitive enhancement reaches a significant level. In addition, the investigators will explore the possible predictive indicators of effective treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inform consent acquired
- •Age 20 to 50
- •Right-handed
- •Patients with schizophrenia diagnosed according to DSM-5 criteria
排除标准
- •Participants who are pregnant or breastfeeding
- •Participants who have metal implants
- •Participants who have alcohol/substance use disorder or received electro-convulsive therapy within the past 6 months.
- •Participants who have history of head injury with loss of consciousness
- •Participants who have history of brain lesions, infection, or epilepsy
- •Skin lesions on the electrodes placed
- •Cancer patients
- •Patients with high fever
- •Patients with significant sensory loss
结局指标
主要结局
Visual-spatial working memory span measured by Corsi Block-Tapping task
时间窗: up to one hour
The paradigm was computer-adaptive, and thus the set size would only increase if the participant passed consecutive two trials of the same span. The lowest span level started from 2 (2 squares that change color) and up to 9 as maximum.
Verbal working memory measured by digit-span test
时间窗: up to one hour
The paradigm was also computer-adaptive
次要结局
未报告次要终点
研究者
Wang Jiunn-Kae
Attending physician of psychiatry department
Taipei Medical University Shuang Ho Hospital