Rehabilitation of Social Cognition in Subjects With Traumatic Brain Injury. Efficiency of a Computer Rehabilitation Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Pictures of facial Affect (POFA)
研究概览
简要总结
In the present study the investigators aim to analyze the performance in a battery of social cognition tests of subjects with traumatic brain injury.
On the other hand, the effectiveness of a computerized rehabilitation program designed to improve these deficits will be tested, as well as the relationship between social cognition and executive functioning.
详细描述
The ability of the individual to know how to adopt the perspective of the other or be able to interpret and correctly identify their emotions, is essential for their proper development in society. The term Social Cognition would be the construct that would encompass these cognitive processes.
People who have suffered a moderate or severe traumatic brain injury usually show, as reflected in the existing literature, an alteration in the functioning of Social Cognition, leading to problematic or inappropriate behaviors. These deficits have devastating consequences, at a personal, family and economic / labor level.
There is an important debate regarding the independence of the Social Cognition construct from the rest of cognitive functions and in particular with respect to executive functions, probably due to the overlapping of the neuroanatomical structures related to each of these functions.
In the present study a clinical trial will be conducted with a sample of 30 patients admitted to the Guttmann Institute Neurorehabilitation Hospital who have suffered a moderate or severe TBI.
Patients will be divided into two groups depending on whether they receive cognitive rehabilitation treatment focused on attention, memory and executive functions (Control Group) or if, in addition to this treatment, the computerized treatment module for the rehabilitation of CS is also applied. (Experimental Group). Both types of treatment would be carried out using the cognitive telerehabilitation platform Guttmann, NeuroPersonalTrainer® (GNPT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at the time of the TBI equal to or greater than 18 years.
- •Evolution time between the TBI and the beginning of the participation in the study less than 6 months.
- •Find out from the Post-Traumatic Amnesia Phase, evaluated through the Galveston Orientation and Amnesia Test (GOAT) scale: it is considered that the patient is out of PTA if he obtains scores greater than 75 in two consecutive administrations.
- •Cognitive impairment through the neuropsychological scan battery that is administered by clinical protocol.
排除标准
- •Alteration of the language that compromises the complete application of the neuropsychological exploration battery.
- •Psychiatric history or neurological involvement prior to TBI.
结局指标
主要结局
Pictures of facial Affect (POFA)
时间窗: 1 day
It is an assessment test of the ability to identify basic emotions in facial. This subtest has a puntuation range from 0 to 65, where higher values are considered to be a better outcome. expressions
Social Decision Making Task The Social Decision Making Task (SDMT)
时间窗: 1 day
Pseudo online test of catch and throw where the participant is required to use social feedback.
International Affect Picture System (IAPS)
时间窗: 1 day
Designed to provide a standardized set of pictures for studying emotion and attention. This subtest has a puntuation range from 0 to 25, where higher values are considered to be a better outcome.
The Moving Shapes Paradigm
时间窗: 1 day
Evaluation of the interaction between two triangles based on low level. This subtest has a puntuation range from 0 to 12, where higher values are considered to be a better outcome. inferences
Reading The Mind in the Eyes Test (RMET)
时间窗: 1 day
Advanced test of theory of mind. The subject must identify emotions in the eyes of photographed people. This subtest has a puntuation range from 0 to 36, where higher values are considered to be a better outcome.
次要结局
- Rey Auditory Verbal Learning Test (RAVLT)(1 day)
- Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
- Conners Continuous Performance Test (CPT-II)(1 day)
- Spanish phonemic fluency test- PMR(1 day)
- Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
- Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
- Digit Symbol-Coding Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
- Block Design Subtest from the Wechsler Adult Intelligence Scale (WAIS-III)(1 day)
- Stroop Color and Word test (Stroop Test)(1 day)
- Trail Making Test A (TMT-A)(1 day)
- Trail Making Test B (TMT-B)(1 day)
- Wisconsin Card Sorting Test (WCST)(1 day)
研究者
Pablo Rodriguez
Principal Investigator
Institut Guttmann