Validation of Cognitive Enhancement Techniques for Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Change in cognitive impairment
研究概览
简要总结
With an average of 21,000 diagnosed brain injuries each year among military personnel, traumatic brain injury (TBI) remains a major health concern for the United States Military Health System. Mild traumatic brain injury (mTBI) is the most common type of brain injury sustained by military personnel and may result in chronic cognitive impairment.Unfortunately, many service members (SMs) have a history of multiple head injuries as well as psychological co-morbidities that negatively influence recovery. Advances in treatment options for cognitive rehabilitation following mTBI have been of increasing interest to the medical community and may increase treatment efficacy for injured SMs to ensure force readiness.
Cognitive Rehabilitation (CR) for severe brain injury focuses on compensatory strategies for activities of daily living such as using lists to remember grocery items or reminders to take medications and attend medical appointments. Research has shown CR interventions to have considerable effectiveness in the acute and sub-acute phase of recovery after severe TBI. But there is insufficient evidence that they improve rates of individuals returning to work, independence in activities of daily living (ADL), community re-integration, or quality of life.
详细描述
Cognitive Rehabilitation for mild brain injury has shown some modest evidence of effectiveness. CR interventions for mTBI typically focus on compensating for subjective and functional cognitive complaints. A number of recent studies have examined the use of compensatory CR approaches for individuals (primarily military veterans) diagnosed with mild cognitive impairment from a likely mTBI. These interventions taught individuals adaptive functional skills (e.g., cognitive mnemonics) and highlighted use of external aids such as smart phone scheduling/reminder applications. A randomized control trial that included 16 veterans with TBI (mixed mild and moderate severity), found this compensatory CR intervention was effective at reducing overall symptoms, but did not impact cognitive performance or work-outcomes. In a secondary study, there was some evidence that the compensatory CR intervention improved memory at 6 months post-treatment and quality of life at 12 months but there was not a consistent pattern of improvement compared to controls.
Generalizability from civilian and veteran communities to active duty SMs may pose some unique and unexplored factors as the goal of treatment is not remediation of common activities of daily living (e.g., remembering appointments) but in contrast, the goal is military readiness needed for worldwide deployability to potential wartime environments (e.g., "cognitive readiness").
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Male or female ages 18 years or older
- •Active duty military personnel
- •History of mTBI: participants will have a history of at least one mTBI sustained >3 months previously based on criteria of the DoD diagnostic criteria (Department of Veterans Affairs and Department of Defense, 2016). This specifies an external force to the head which resulted in physiological dysfunction of the brain as manifested by one or more of the following acute symptoms:
- •Any loss of consciousness (not to exceed 30 minutes)
- •Any loss of memory for the events immediately before or after the injury (not to exceed 1 day)
- •Any alteration of consciousness or change in mental state (not to exceed 24 hours)
- •Persistent Post-Concussive Symptoms: Participants will endorse elevated neurobehavioral symptomatology compared to published normative data (Soble et al. 2014), with at least one cognitive symptom (e.g., a score of 3 or greater on at least one of the four items on the NSI cognitive domain).
排除标准
- •• History of TBI (any severity) within 3 months of enrollment.
- •History of moderate, severe, or penetrating TBI as defined by DOD/VA guidelines during their lifetime
- •Current substance use disorder based on patient self-report.
- •History of a neurological disease other than mild TBI such as multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder.
- •Current, active suicidal or homicidal ideation.
- •Impaired decision-making capacity.
结局指标
主要结局
Change in cognitive impairment
时间窗: 4 MONTHS
Cognitive impairment will be measured using the Global Deficit Score (GDS) which allows for the detection of subtle and varied degree of impairment from multiple measures.
次要结局
- Change in healthcare utilization(4.5 MONTHS)
- Change in level of occupational performance(4.5 MONTHS)