Enhancing Cognitive and Neurobehavioral Functions After Repetitive Traumatic Brain Injuries (rTBI) in Retired NFL Players and Military Veterans.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Participant reported outcomes
研究概览
简要总结
The purpose of this study is to compare different combinations of cognitive training in retired professional football players and military veterans with a history of repeated concussions and persistent symptoms of impaired memory, concentration, attention, focus, or thinking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of >1 Mild TBI: post traumatic amnesia/confusion ≤ 24 hour immediately after injury; or loss of consciousness <30 min confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF).
- •Age 25-55 years
- •Minimum of 4 months post-injury
- •Adequate visual, auditory, sensory-motor function for training program.
- •Fluent in English
- •Persistent cognitive dysfunction confirmed by Ruff Neurobehavioral Inventory score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive).
排除标准
- •History of hypoxic event
- •Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders.
- •Current illicit drug use or alcohol abuse
- •Unwilling or unable (e.g. language barrier) to participate
- •Hospitalization during study
- •Current Litigation
- •Positive on malingering test
- •Use of medications to enhance cognitive function (e.g. Ritalin)
- •Initial Glasgow Coma Score < 13 or penetrating head injury
- •Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale. Subjects with a score of 4 or 5 (as recommended by the FDA for treatment trials) will be excluded and referred for appropriate treatment.
- •Subjects should not be enrolled in a concurrent TBI clinical trial.
结局指标
主要结局
Participant reported outcomes
时间窗: within one week following treatment completion.
Measure of impact of program use on the patient's own view of their impairment and function.
Composite performance score based on battery of neuropsychological tests of working memory, learning, memory, and executive function.
时间窗: within one week following treatment completion
Composite performance score on neuropsychological battery based on four primary domains : learning, memory, working memory, and executive function.
Working/school status
时间窗: within one week following treatment completion.
Measure of participants' employment status, and the number of hours worked/volunteered/in-school per week.
Exercise-base assessments
时间窗: within one week following treatment completion.
Four sets of assessments that are closely modeled on study-related exercises in the auditory, visual, cognitive, and social-cognitive modules. These include auditory speed of processing, visual speed of processing, cognitive control speed of processing and face recognition, recall of unique faces, and emotional cue recognition.
Functional assessments
时间窗: within one week following treatment completion.
Timed instrumental activities of daily living (TIADL) and the Mayo-Portland Adaptability Inventory (MPAI-4) for sensitive directly observed performance and well-accepted clinical impression measures.
次要结局
未报告次要终点
研究者
Robert W. Van Boven, M.D., D.D.S.
Director
Brain & Body Health Foundation