Transcranial Direct Current Stimulation and Computer-based Training for the Rehabilitation of Cognitive Function in Traumatic Brain Injury: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline executive function at 10 days of intervention (scale assessment)
研究概览
简要总结
Traumatic Brain Injury (TBI) is a serious public health problem due to its high mortality and morbidity rates, mainly affecting young adult males. Aggression to the prefrontal cortex, caused by an external physical force, responsible for anatomical injury and/or functional impairment, causes cognitive deficits with important consequences for the individual affected by the trauma and their caregivers. Therefore, rehabilitation is of utmost importance. The increase in pre-frontal cortical activation through training, activity-dependent stimulation and neuroplasticity, especially in the dorsolateral prefrontal cortex (DLPFC) is related to better performance in functional memory. In this context, Transcranial Direct Current Stimulation (tDCS), intended to drive neuroplastic changes in the brain, has been widely used to bring benefits to the cognitive function of individuals affected by various neurological conditions, including TBI by promoting neuroplasticity for critically involved cortical areas in the performance of tasks, culminating in cognitive benefits. In addition, studies have shown greater benefits when the technique is combined with cognitive training. Therefore, the objective of this parallel, randomized, double-blind, placebo-controlled clinical trial is to investigate the effect of tDCS applied on the dorsolateral prefrontal cortex and virtual reality cognitive training alone or in association with tDCS on cognitive function of individuals with severe chronic TBI.
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
- Triple (Participant, 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
- •Chronic TBI (≥ 12 months)
- •Severe TBI (Glasgow ≤ 8, loss of consciousness > 24 hours, post-traumatic amnesia > 1 week)
- •Working memory, attention or executive deficit
- •Score in Mini Mental State Examination according the cut-off point (i.e, 13 to illiterates individuals, 18 to low and medium schooling and 26 to high schooling).
排除标准
- •Individuals unable to perform the activities proposed in the study protocol (e.g. physical deficits, lack of collaboration, aphasia, accuses, amaurosis)
- •Mid or extensive cranial defects
- •Titanium cranial prosthesis
- •Extensive cranial prosthesis located on the dorsal prefrontal cortex
- •Metallic devices implanted in the brain
- •Psychotic disorders
- •Recent history of alcoholism or use of drugs
- •Neurological diseases (e.g Parkinson, Stroke, Alzheimer).
研究组 & 干预措施
tDCS plus Computer-assisted training
Patients will receive 10 sessions of active anodal tDCS on the left prefrontal cortex dorsolateral (F3 area using International 10-20 system for electroencephalogram (EEG) electrode placement) plus Computer-assisted cognitive training (games to improve working memory, attention, and executive function).
干预措施: Computer-assisted training (Device)
tDCS plus Computer-assisted training
Patients will receive 10 sessions of active anodal tDCS on the left prefrontal cortex dorsolateral (F3 area using International 10-20 system for electroencephalogram (EEG) electrode placement) plus Computer-assisted cognitive training (games to improve working memory, attention, and executive function).
干预措施: anodal tDCS (Device)
tDCS sham plus Computer-assisted training
Patients will receive 10 sessions of sham anodal tDCS on the left prefrontal cortex dorsolateral plus Computer-assisted cognitive training (games to improve working memory, attention and executive function).
干预措施: Computer-assisted training (Device)
tDCS sham plus Computer-assisted training
Patients will receive 10 sessions of sham anodal tDCS on the left prefrontal cortex dorsolateral plus Computer-assisted cognitive training (games to improve working memory, attention and executive function).
干预措施: sham tDCS (Device)
结局指标
主要结局
Change from baseline executive function at 10 days of intervention (scale assessment)
时间窗: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
This assessment will occur through the Trail Making Test A and B, which provides information on visual search, scanning, speed of processing, mental flexibility, and executive functions. It requires the subject to connect encircled numbers randomly arranged on a page (Part A) and encircled numbers and letters in alternating order (Part B). Scoring is expressed in time in seconds required for completion of each of the two parts of the test. Scoring is expressed in terms of the time in seconds required for completion of each of the two parts of the test, on which the shorter the time to complete the task the better the performance (i.e part A \< 180 s and part B \< 300 s).
Change from baseline attention and executive function at 10 days of intervention (scale assessment)
时间窗: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
This assessment will occur through the Stroop Color and Word Test, which assesses the ease with which a person can maintain a goal in mind and suppress the habitual response in favor of a less familiar one (i.e selective attention and cognitive flexibility). Both the time to complete and the number of errors. In addition, the interference effect is determined by calculating the extra time required to name colors in the interference task in comparison to the time required to name colors in the control task.
Change from baseline working memory at 10 days of intervention (scale assessment)
时间窗: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, i.e 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
Will be performed throughWechsler Adult Intelligence Scale IV (Digit span, Letter-Number Sequencing and Arithmetic subtests). These subtests evaluates the working memory and attention. The Digit span involves a forward and a backward recitation condition. The maximum score is 30 points, where higher score indicates better the performance. Letter-Number sequencing involves a combination of numbers and letters that must be recited.The maximum scores is 21 points, where higher scores shows better performance. The Arithmetic subtest is formed by some calculations must be solved without the aid of paper and pen. The maximum score is 22 points in which higher scores indicates better performance. The score of each subtest will be considered separately for characterization of the working memory. In addition, The sum of the weighted individual scores in each subtest will be calculated for the Working Memory Index.
Change from baseline processing speed at 10 days of intervention (scale assessment)
时间窗: We will apply these instruments at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
This assessment will occur through the Code Search subtest (WAIS), which as evaluates the processing speed to complete a card with number and symbols that must be related to a correct execution of the test. The score is formulated based on correct answers. The maximum score is 133 points. The higher scores are related to better performance.
Change from baseline working memory at 10 days of intervention (computer-based assessment)
时间窗: We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).
This assessment will occur through the Genius game, which will evaluate the performance in the unit of measure of execution time (i.e. seconds) of the task.
次要结局
- Change from baseline quality of life at 10 days of intervention(We will apply the QOLIBRI at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).)
- Change from baseline processing speed at 10 days of intervention (computer-based assessment)(We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).)
- Change from baseline depression at 10 days of intervention(We will apply the BDI at T0 (baseline time), T2 (at end of all sessions, ie 10 days after the first session) and and T3 (i.e after 1 month of follow-up time).)
- Change from baseline reasoning and planning at 10 days of intervention (computer-based assessment)(We will apply these instruments at T0 (baseline time), T1 (one day after the first session), T2 (at end of all sessions, ie 10 days after the first session) and T3 (i.e after 1 month of follow-up time).)
研究者
Renato Anghinah
Doctor
University of Sao Paulo General Hospital