Effect of Fixed vs. Tailored Intensity Transcranial Direct Current Stimulation for Attention Deficit After Traumatic Brain Injury: a Single Center, Prospective, Double Blind, Randomized-Controlled Clinical Trial, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Auditory Continuous Performance Test (aCPT) response time
研究概览
简要总结
Traumatic brain injury (TBI) is an important global health concern. Recently, advances in neurocritical care have led to an increase in the number of recovering TBI patients, and concomittantly in the incidence of complications of TBI. One of the most important sequalae of TBI is cognitive deficit, for which multimodal rehabilitation approach is indicated. Transcranial direct current stimulation (tDCS) is a promising treatment strategy for post-TBI cognitive deficits. However, a standardized tailored tDCS protocol is yet to be established for TBI patients. Therefore, this trial aims to 1) the efficacy of tDCS on post-TBI cognitive deficits, and 2) and optimized protocol of tDCS on post-TBI cognitive deficits via a three-arm double-blind, randomized controlled trial.
详细描述
Traumatic brain injury (TBI) is an important global health concern. It is estimated that about 70 million individuals will suffer a traumatic brain injury (TBI) each year. Serious TBIs for hospitalization or death is at least 10 million annually. In 2006, Langlois et al reported that, 50,000 patients die directly from or complications related to TBI in the united states alone, and at least 5.3 million Americans suffer from long-term disabilities related to TBI.
Recently, advances in neurocritical care have led to an increase in the number of severe TBI patients recovering cognitive and physical function, eventually returning to independent life.
With the rising recovery rate of TBI patients, the number of complications of TBI is also rising. One of the most common sequalae of TBI is cognitive deficit. In 2004, Whiteneck et al reported that about 65% of patients who experienced moderate to severe TBI suffer from long-term cognitive deficit. Mild TBI patients show fewer and lighter symptoms of cognitive deficit. However, about 15% of patients suffer from persisting cognitive, emotional, behavioral, and physical disabilities after one year (Roe et al. Disabil Rehabil. 2009).
Common symptoms of post-TBI cognitive deficit are attention deficit, memory loss, and impaired cognitive proceessing (Salmond et al. Curr Opin Crit Care. 2005). Current treatment strategy of post-TBI cognitive rehabilitation constitute multimodal approach including "conventional" occupational therapy, computerized neurocognitive training (CNT), pharmacotherapy, and physical medicine.
Transcranial direct current stimulation (tDCS) is a treatment approach where direct current is applied transcranially, aiming to modulate local neuronal excitability. Previous researches have established that repeated tDCS is safe, cost-effective, and easily administered to various neurological disorders including TBI, stroke, Parkinsonism, Alzheimer's dementia, and multiple sclerosis.
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)
盲法说明
Prospective, Double Blind, Randomized Controlled Clinical Trial ,
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years or older
- •At least 6 months since traumatic brain injury
- •Cognitive disability measured by:
- •A) K-MoCA score 25 or below, or B) Trail making test A > 50.25s or B > 142.53s
排除标准
- •Infection, open wound, bleeding, skull defect, or metal plates at or near tDCS site
- •history of seizure
- •Language disorder
- •Serious cognitive deficit with K-MoCA score below 10
- •Pregnancy or possibility of pregnancy
- •MRI contraindications
- •Previous medical history that may affect the patient's cognitive abilities (i.e. previous stroke, hypoxic ischemic encephalopathy, schizophrenia)
- •Change in dosage of the following medications within the previous 2 weeks
- •rivastigmine
- •donepezil
- •memantine
- •antiepiletic medications
结局指标
主要结局
Auditory Continuous Performance Test (aCPT) response time
时间窗: 6 weeks
The Auditory Continuous Performance Test (ACPT) screens for auditory attention deficits. In the test, patients are told that they will see or hear the numbers "1" or "2" and that they are to click the mouse when presented with a visual or auditory "1" and inhibit clicking when presented with a "2". The task is made more challenging by the shifting of modalities between the visual and auditory stimuli. Data are provided for over-all attentional functioning and response control, as well as separate visual and auditory attention and response control.
次要结局
- Auditory Continuous Performance Test (aCPT) omission error, commission error(6 weeks)
- Cambridge Neuropsychological Test Automated Battery (CANTAB)(6 weeks)
- Computerized Neurocognitive Test (CNT)(6 weeks)
