Assessing Neurophysiological Changes in Individuals With Chronic Traumatic Brain Injury Symptoms Throughout a Full-time or Part-time Holistic Cognitive Rehabilitation Program: An Initial Assessment.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Tracking and comparison of neurophysiological changes (response size) to functional changes as participants complete 3 months of the ABIW program.
研究概览
简要总结
Symptoms resulting from mild/moderate trauma to the brain are as varied as the individuals who sustain them. The currently held belief is that the majority of healing and functional recovery occurs within the first two years post injury. A large proportion of individuals who sustain mild/moderate brain injuries (mTBIs) do not fully recover, and continue to experience symptoms well beyond two years post injury. Cognitive rehabilitation programs have been shown to be somewhat effective in helping mTBI patients regain some functionality in these executive domains.
The purpose of the current study is to use an objective assessment of brain function to track changes during either a full-time or part-time holistic cognitive rehabilitation program, specifically the ABI Wellness (ABIW) program. The NeuroCatch Platform™ test will be used to assess brain functioning before, during and after 3 months in the ABIW program. The NeuroCatch Platform™ test uses electroencephalography (EEG) to measure event-related potential (ERP) signals produced by the brain, in response to an auditory stimulus. Three brain processes are examined with this test: Auditory sensation (ERP marker is the N100), Basic attention (ERP marker is the P300), and Cognitive processing (ERP marker is the N400).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in but not initiated the ABI Wellness program
- •Male or female, 19-65 years old inclusively
- •Normal hearing capabilities
- •Able to understand the informed consent form, study procedures and willing to participate in study
- •Able to keep eyes still for 6 minutes
排除标准
- •Clinically documented hearing issues (e.g. in-ear hearing problems, punctured ear drum, etc.)
- •Score of 7 or lower on the Mini Mental State Exam (MMSE) - Orientation subscale
- •Implanted pacemaker
- •Metal or plastic implants in skull
- •In-ear hearing aid or cochlear implant, hearing device
- •Recent (within last 6 months) acquired brain injury
- •History of other neurological disorder (e.g. brain cancer, dementia, multiple sclerosis, stroke, etc.)
- •Exposed to investigational drug or device 30 days prior to start in this study, or concurrent use of investigational drug or device while enrolled in this study
- •Not fluent in English language
- •Unable to provide informed consent
- •Previous participation in studies using the NeuroCatch Platform™
- •If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
- •History of seizures
- •Allergy to rubbing alcohol or EEG gel
结局指标
主要结局
Tracking and comparison of neurophysiological changes (response size) to functional changes as participants complete 3 months of the ABIW program.
时间窗: 3 months
Response size will be measured as amplitude in microvolts. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.
Tracking and comparison of neurophysiological changes (response timing) to functional changes as participants complete 3 months of the ABIW program.
时间窗: 3 months
Response timing will be measured as latency in milliseconds. Functional changes will be measured using a proprietary BrainEx Assessment that provides a category score from four cognitive programs of BrainEx.
次要结局
- Collection and evaluation of adverse events and adverse device effects(3 months)