The Brain Injury Neurorehabilitation Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Memory
研究概览
简要总结
The primary objective of The Brain Injury Neurorehabilitation Project is a systematic effort to generate cutting edge research in brain injury and cognitive rehabilitation that will advance neurorehabilitation research. It will establish the first surveillance system and implement multimodal data to characterize the long-term effects of moderate to severe TBI. Additionally, the project will implement innovative rehabilitation methodologies, namely, cognitive training, social communication deficits and non-invasive brain stimulation with tDCS, to determine which modality can improve neurocognitive and psychosocial performance in adult ABI. Two funded projects, BRAIN-REHAB & ACESO are incorporated in this project.
详细描述
Acquired Brain Injury resulting from a TBI or CVA is a primary cause of chronic disability and unemployment, resulting in significant health, societal, and financial burden. The Brain Injury Neurorehabilitation Project is part of a systematic effort to study ABI in Cyprus. It is an umbrella project designed to generate cutting edge research in brain injury and cognitive rehabilitation that will advance neurorehabilitation research. Patients with TBI and strokes are often faced with cognitive and behavioral difficulties that interfere with their ability to return to productive living, thus contributing to unemployment, social isolation and low quality of life for decades post injury. The scientific objectives will address the aforementioned challenge. First, the project will establish the first TBI surveillance system in Cyprus and implement epidemiologically-principled and systematic data collection from large cohorts across the severity continuum. It will integrate neuropsychological, lifestyle, injury, imaging, genetic, and biological data using state of the art computational methods and quantitatively assess the exact contribution of critical variables to brain injury recovery. Second, the project will determine the effectiveness of a theory-driven neurocognitive therapy program, the Categorization Program (CP) in combination with a social-communication training during the chronic phase of the recovery process. It is hypothesized that the combination of remedial cognitive and social-communication training will yield improvement in functioning with sustainable long term effects. Additionally, the project will implement non-invasive brain stimulation (NIBS) in combination with the social-communication intervention to determine the utility of NIBS and specifically tDCS, in improving cognitive performance and psychosocial functioning. Through innovative research and development of new methods and technologies, the project will advance the State-of-the-Art by producing cutting edge research with international impact while contributing to the development of personalized medicine and improvement of rehabilitation outcomes and reduction of disability in Cyprus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe TBI or hospitalization due to CVA
排除标准
- •history of neurodevelopmental disorder, prior neurological history or psychiatric history requiring hospitalization
结局指标
主要结局
Memory
时间窗: Administered pre & post training at 3 & 6 months follow up
The Greek version of the Auditory Verbal Learning Test will be used as a key outcome for memory. The test consists of a list of 15 items read to the participant, and the participant is required to recall as many items from the list. Maximum score per trial is 15. The process is repeated 5 times (presentation of the list and subsequent recall) for a possible maximum score of 60. A thirty-minute delay is also included after the five learning trials. The measure allows exploring a number of memory processes, such as short term memory (trial one), working memory (list learning across the five trials) and episodic memory (ability to recall items on the list after the 30-minute delay).
Language
时间窗: Administered Pre and Post training at 3 & 6 months follow up
Expressive and receptive language, including naming and verbal fluency, will be used. For this task, we will use the Greek short version of the Peabody Picture Vocabulary test (maximum score of 32) the Greek Short Version of the Boston Naming Test (maximum score of 20). In addition, animal naming in 60 seconds and words from letter F in 60 seconds will be used for verbal fluency. For all tasks, higher scores indicate better performance.
Executive Functioning
时间窗: Administered pre & post training at 3 & 6 months follow up
Laboratory and structured questionnaires will be used to assess executive functions. Laboratory tests include the Trail Making A and B (performance is measured in seconds; the faster, the better), and the Symbol Digits Modalities task (completion of as many items as possible in 90 seconds; higher score is better). In addition, the Dysexecutive Questionnaire will be completed by the participant and a close informant, to assess everyday executive functioning abilities. Maximum score is 148 and the lower score indicates better executive abilities.
次要结局
- Depression(Adminisered pre & post training at 3 & 6 months follow up)
- WHO-BREF Quality of Life(Adminsitered pre & post training at 3 & 6 months follow up)
研究者
Fofi Constantinidou
Professor of Psychology
University of Cyprus