Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury

赞助:

合作者:

信息的提供 (责任方):

Adria Garcia Rosas，Institut Guttmann

追踪信息

首次提交日期 ^ICMJE

October 3, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 2018

预计主要完成日期

September 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Conners Continuous Performance Test (CPT-II)[ Time Frame: 1 day ]

To improve performance in sustained attention after receiving experimental intervention.

Digit Span Forward from the Wechsler Adult Intelligence Scale[ Time Frame: 1 day ]

To improve performance in span of immediate verbal recall after receiving experimental intervention.

Digit Span Backward from the Wechsler Adult Intelligence Scale[ Time Frame: 1 day ]

To improve performance in working memory after receiving experimental intervention.

Rey Auditory Verbal Learning Test[ Time Frame: 1 day ]

To improve performance in short-term, long-term and recognition.

Letters and Numbers from the Wechsler Adult Intelligence Scale[ Time Frame: 1 day ]

To improve performance in working memory after receiving experimental intervention.

Spanish phonemic fluency test (PMR)[ Time Frame: 1 day ]

To improve performance in phonemic fluency after receiving experimental intervention.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Trail Making Test A (TMT-A)[ Time Frame: 1 day ]
To improve performance in visual attention
Trail Making Test B (TMT-B)[ Time Frame: 1 day ]
To improve performance in task-switching
Wisconsin Card Sorting Test (WCST)[ Time Frame: 1 day ]
To improve performance in set-shifting
Stroop Color and Word test (Stroop Test)[ Time Frame: 1 day ]
To improve performance in inhibitory control

描述性信息

简略标题 ^ICMJE

Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury

正式标题 ^ICMJE

Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury

简要概况

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.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: Real tRNS
The treatment consists of a set of 1-h sessions, three sessions per week for 8 weeks. A series of cognitive exercises of attention, memory, and executive functions will be conducted in each session. During the first 20 minutes of each cognitive training session, patients will receive bi-frontal and bi-parietal tRNS. It has a start and end ramp of two seconds in each case to avoid the slight unpleasant sensation that occurs in the first moments of the introduction of direct current DC.
Other: Sham tRNS
The treatment consists of a set of 1-h sessions, three sessions per week for 8 weeks. A series of cognitive exercises of attention, memory, and executive functions will be conducted in each session. We will apply a sham tRNS for the first 20 minutes of each cognitive training session. The subjects will receive sham tRNS and will perform the same type of cognitive training as the rest of patients and will receive the same type of adverse reaction questionnaire. Subjects receiving simulated stimulation will receive the same type of ramps at the beginning and end of the session to ensure triple-blind maintenance .

研究工具

Experimental: Real tRNS
Real tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.
Sham Comparator: Sham tRNS
Sham tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 2020

预计主要完成日期

September 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Spain

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Adria Garcia Rosas，Institut Guttmann

研究赞助商 ^ICMJE

Institut Guttmann

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

Institut Guttmann

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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