tDCS in Patients With Mild Traumatic Brain Injury and Persistent Post Concussion Syndrome: Randomized Crossover Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test
研究概览
简要总结
The purpose of this study is to determine the early effects of transcranial direct current stimulation (tDCS) in patients with mild traumatic brain injury and persistent post concussion syndrome(PPCS) with cognitive deficits in long term episodic memory and executive function(inhibitory control).
详细描述
This is a randomized crossover trial of patients with mild TBI (mTBI) sustaining PPCS. It will be recruited twenty adult patients who will receive three sessions of anodal tDCS: left dorsolateral prefrontal cortex, left temporal cortex(with an intensity of 1.5 mA for 20 min) and sham stimulation(intensity of 1.5 mA for 30 seconds only). Sessions will be performed with at least 7 days of interval(wash out period) in a randomized order. Patients who meet the inclusion criteria will be assessed with a neuropsychological evaluation - battery tests include Beck Depression Scale, Hopkins Verbal Learning(HVLT), Stroop test and digit, letters and numbers sequence. A new battery of computerized neuropsychological test will be performed before and immediately after each stimulation(HVLT, Wechsler memory scale, Inhibitory control test(ICT) and block-tapping test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, 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
- •history of mild traumatic brain injury on hospital admission
- •subjective complain of memory and executive function
- •must be able to sign the Informed Consent Form
排除标准
- •under or over age limits
- •no specific complain of memory and executive function
- •history of major depression(Beck Inventory>35)
- •drug addiction
- •uncontrolled epilepsy
- •presence of any metallic prosthesis implant
- •presence of cochlear implant
- •not able to sign the Informed Consent Form
结局指标
主要结局
Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test
时间窗: immediately after the stimulation
HVLT, Wechsler memory scale, Inhibitory control test(ICT) and Block-tapping test.
次要结局
未报告次要终点