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临床试验/NCT06074328
NCT06074328已完成不适用

Blended Reality Immersion for Geriatric Head Trauma: The BRIGHT Randomized Clinical Trial

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Change in the immediate memory domain score on the Repeatable Battery for Neuropsychological Assessment

研究概览

简要总结

Traumatic brain injury (TBI) is a major public health concern, particularly among older adults (OAs) ≥ 65 years of age. Each year in the United States, TBI results in over 600,000 emergency department visits and hospitalizations among OAs. Mild TBI (mTBI) accounts for 80% of all TBI in OAs and is quite understudied in this rapidly growing population. mTBI, is mild in name only, as it can result in dysfunction in multiple cognitive domains, including attention, processing speed, executive functioning and memory and has been shown to be associated with progressive brain atrophy and increased susceptibility to neurodegenerative disorders. Cognitive rehabilitation therapy is an evidence-based approach that can successfully improve cognitive impairment following TBI. Virtual reality (VR) is emerging as a technology that can assess cognitive impairment and provide a neurorehabilitation modality (NRM) to improve cognitive decline post TBI. Not only can VR provide a variety of environments like those encountered in real life and be adapted to varying levels and types of cognitive disability, but it can also be used safely in a patient's home with minimal equipment. Yet, despite the promise of cognitive rehabilitation using VR among OAs, very few studies to date have assessed the efficacy of VR cognitive rehabilitation in TBI. The aim of this study is to assess the effect and collect data on the efficacy and feasibility of a virtual reality application as a neurorehabilitation modality on executive functioning (attention, immediate memory, and visual-spatial skills) in OAs with mTBI. The hypothesis is that The use of VR mediated cognitive exercises post mTBI will be associated with improved executive function at 6-weeks post-randomization compared to the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 years of age or older
  • Diagnosed with a mild traumatic brain injury
  • Community dwelling
  • English speaking
  • Live within a 30 mile radius from the trauma center
  • Active phone number
  • Able to provide informed consent

排除标准

  • Known history of cognitive impairment
  • Known history of functional impairment
  • History of seizure disorders
  • Medical implantable devices ( pacemaker & defibrillator)
  • Substance use disorder
  • Other severe traumatic injuries to the neck, chest, abdomen, spine and pelvis

结局指标

主要结局

Change in the immediate memory domain score on the Repeatable Battery for Neuropsychological Assessment

时间窗: 7 weeks post enrollment

individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory. The SCORES range from 40-160 with a mean and standard deviation of 100 and 15. Higher score = better outcome

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mira Ghneim

Assistant Professor Program In Trauma

University of Maryland, Baltimore

研究点 (2)

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