Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Letters and Numbers from the Wechsler Adult Intelligence Scale
研究概览
简要总结
The main objective of this study is to evaluate the effects of tRNS while undergoing computerized cognitive rehabilitation therapy to conclude if this combination of therapies would be effective for the cognitive rehabilitation of patients with acquired brain damage, such as traumatic brain injury. We want to study the therapeutic potential of tRNS to enhance the therapeutic outcome of cognitive training, studying its global effect over the rehabilitation of attention, memory and executive functions, compared to sham tRNS.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years old
- •documented history of severe or moderate TBI (severe TBI: Glasgow Coma Scale 3-8; moderate TBI: Glasgow Coma Scale 9-13)
- •out of post-traumatic amnesia
- •less than 6 months after TBI
- •cognitive impairment objectified by neuropsychological exploration.
排除标准
- •impairment of language, affecting the production and/or comprehension of speech and the ability to read and/or write
- •severe alteration of the visual field or visual perception problems that limits the use of technological devices
- •sever motor impairment of both upper extremities that prevent the use of technological devices
- •previous or current history of psychiatric, neurological or systemic alterations that affect the central nervous system
- •history of substance abuse
- •dermatological diseases in the skull
- •presence of metal implants or holes in the skull
- •epilepsy.
结局指标
主要结局
Letters and Numbers from the Wechsler Adult Intelligence Scale
时间窗: 1 day
To improve performance in working memory after receiving experimental intervention.
Rey Auditory Verbal Learning Test
时间窗: 1 day
To improve performance in short-term, long-term and recognition.
Conners Continuous Performance Test (CPT-II)
时间窗: 1 day
To improve performance in sustained attention after receiving experimental intervention.
Digit Span Forward from the Wechsler Adult Intelligence Scale
时间窗: 1 day
To improve performance in span of immediate verbal recall after receiving experimental intervention.
Digit Span Backward from the Wechsler Adult Intelligence Scale
时间窗: 1 day
To improve performance in working memory after receiving experimental intervention.
Spanish phonemic fluency test (PMR)
时间窗: 1 day
To improve performance in phonemic fluency after receiving experimental intervention.
次要结局
- Trail Making Test A (TMT-A)(1 day)
- Stroop Color and Word test (Stroop Test)(1 day)
- Trail Making Test B (TMT-B)(1 day)
- Wisconsin Card Sorting Test (WCST)(1 day)
研究者
Adria Garcia Rosas
PhD Student
Institut Guttmann