A Health Game Intervention for Cancer and Post-ICU Patients Suffering From Acute Cognitive Impairment: A Clinical Study to Assess a New Form of Brain Stimulation Therapy With the Potential to Improve Synaptic Plasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Hopkins Verbal Learning and Memory test
研究概览
简要总结
Millions of patients each year suffer from acute cognitive impairment caused by traumatic brain injury, stroke, Parkinson's disease, etc. Despite increasing incidences and morbidity, effective pharmacological interventions continue to show a lack of improvement for brain cancer patients. Studies thus far have shown that non-pharmacological interventions have contributed to early success in addressing some forms of cognitive impairment for patients with cognitive dysfunction. We have built a phase-one fully functioning game Hometown Bound that offers cognitive challenges to patients. The aim of this study is to observe for measured improvement of cognitive function among brain cancer patients, which will be validated by the four cognitive scales, measuring efficacy. The first three scales measure patient baseline impairment before and after game play.
详细描述
After the completion of a usability study, a two-arm, randomized parallel-group efficacy pilot study will be executed with adult brain cancer patients to estimate cognitive improvements using 3 cognitive assessment measures. Arms will include an experimental group (intervention) and the non-gameplay attention group (control).
Experimental group: estimate approximately 10 hours of game play (over 4 weeks) and 1-2 hours of cognitive survey testing will be needed
Control group: It is estimated approximately 10 hours of Word-Search and Crossword Puzzle play (over 4 weeks) and 1-2 hours of cognitive survey testing will be needed.
Patient total duration of the intervention will be four weeks (3X per week) starting approximately one to two weeks after the conclusion of all cancer treatment (chemo and radiation therapy). Depending on the patients' ability/comfort level, we will determine if they are able to use the VR headset and hand controls.
The 3 cognitive scales:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Inclusion criteria of our study are as follows: (1) age 18 years or older, (2) English speaking, (3) Completion of all chemo and radiation therapy and surgical procedures, (4) physical, cognitively, and emotionally able to wear the VR game headset or seat with personal computer flat screen, (5) able to provide consent or through a legally authorized representative, (6) available to play the game three times per week for four consecutive weeks, either in the outpatient clinics or in a location near their home, with the support to provide them transportation to either location and (7) own a cell phone by which they can be reached to make arrangement for testing. Race and gender are not conditions for inclusion in this pilot study.
排除标准
- •Patients are excluded from our study if any of the following conditions are present: (1) history of mental illnesses and other neurodegenerative diseases such as Alzheimer's disease, vascular dementia, or any other form of advanced neurodegenerative or neuro-cognitive diseases, (2) severe psychiatric illness which is not well controlled, (3) suspected or confirmed drug intoxication/overdose; (5) acute neurologic injury such as traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery, (6) uncorrected hearing or vision impairment including legal blindness, (7) incarcerated at the time of study enrollment, (8) enrolled in another clinical trial which does not permit co-enrollment, or (9) any medical condition precluding safe use of VR headset and hand control technology or physical use of personal computer flat screen and touch pads.
研究组 & 干预措施
VR cognitive training platform
The virtual reality cognitive training platform is specifically designed for mild cognitive impairment populations. The system, referred to as: Virtual Reality-Cognitive Rehabilitation Training (VR-CRT) offers advantages over traditional computerized cognitive training programs due to its immersive virtual reality environment with 81 embedded attention exercises. VR-CRT is a scenario goal-driven (game) framework that rewards patients with points and feedback at the end of each module to promote engagement and incentivize use. Automated (backend) game score tracking encourages aspirational behavior and goal setting with each module completion. VR-CRT was designed with three interconnecting virtual reality environments/levels, each with their own (progressively demanding) attention exercises, along with the ability for new training module integration, i.e., plug-ins to maintain game novelty and challenge.
干预措施: VR cognitive training platform (Device)
结局指标
主要结局
Hopkins Verbal Learning and Memory test
时间窗: 4 weeks
The test consists of a 12-item word list, composed of four words from each of the three semantic categories. The participant listens and memorizes the words as the examiner reads the complete word list of 12 items. This is followed by the participant's attempt to recite back the list of words in any order.
Controlled Oral Word Association
时间窗: 4 weeks
This is a verbal fluency test. Participants are instructed to produce as many words as possible in a 1-minute time-period that begin with the letter cues C, F and L, which were originally selected for their increasing difficulty.
Trail Making A-B
时间窗: 4 weeks
This test consists of 25 circles each distributed over a sheet of paper. In Part A, the circles are numbered 1-25 and, in Part B, the circles include both numbers 1-13 and letters A-L. With Part A, the participant is instructed to draw lines to connect the numbers in ascending order and in Part B, the participant is instructed to draw lines to connect the circles in an ascending pattern, while alternating between the numbers and letters (i.e., 1-A, 2-B, 3-C, etc.)
次要结局
未报告次要终点
研究者
Anthony Faiola
Professor
University of Cincinnati