Neurostimulation for Cognitive Enhancement After Stroke (NeuroCog)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Executive Function measured by Dysexecutive Questionnaire (DEX)
研究概览
简要总结
Transcranial direct current stimulation has shown promising results in stroke patients. This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in two different cognitive regions after a stroke. Sixty patients who suffer from chronic strokes will be randomized into 1 of 3 groups: dorsolateral prefrontal cortex, cingulo-opercular network and motor primary cortex (control). Each group will receive transcranial direct current stimulation for 20 minutes for 10 consecutive working days (2 weeks). Patients will be assessed with a Dysexecutive Questionnaire, Semantic Fluency test, categorical verbal fluency and Go-no go tests, Wechsler Adult Intelligence Scale, Rey Auditory-Verbal Learning Test, Letter Comparison and Pattern Comparison Tasks at baseline, after their tenth stimulation session (week 2) and endpoint (week 4). Those who achieve clinical improvement with neurostimulation will be invited to receive treatment for 12 months as part of a follow-up study.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Ischaemic chronic stroke
- •Mild/Moderate Cognitive impairment
- •Informed consent
排除标准
- •National Institute of Health Stroke Scale (NIHSS) ≥ 16 points
- •Severe cognitive comorbidities (dementia, depression)
- •transcranial direct current stimulation criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system
结局指标
主要结局
Executive Function measured by Dysexecutive Questionnaire (DEX)
时间窗: Change for executive functions at 4 weeks
次要结局
- Verbal Fluency (Semantic Fluency Test)([ Time Frame: Baseline, Week 2 and Week 4 ])
- Executive function (Wechsler Intelligence Scale for Adults)([ Time Frame: Baseline, Week 2 and Week 4 ])
- Memory (Rey Auditory Verbal Learning)([ Time Frame: Baseline, Week 2 and Week 4 ])
- Processing Speed (Letter Comparison and Pattern Comparison Tasks)([ Time Frame: Baseline, Week 2 and Week 4 ])
- Response inhibition (Go-no-go Test)([ Time Frame: Baseline, Week 2 and Week 4 ])
研究者
Suellen Marinho Andrade
PhD
Federal University of Paraíba