Poly-omic Predictors of Symptom Duration and Recovery for Adolescent Concussion
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 750
- 试验地点
- 5
- 主要终点
- Presence or absence of concussion recovery 30 days after injury
研究概览
简要总结
The purpose of this study is to identify changes in salivary micro ribonucleic acid (miRNA) levels that are predictive of symptom duration and character following mild traumatic brain injury (mTBI) in children.
详细描述
The objective of this multi-center study is to refine and validate a saliva RNA assessment for youth concussion, yielding a non-invasive test that predicts duration and character of symptoms, and helps guide clinical decisions. To accomplish this goal, the study will enroll 750 youth with mTBI. Saliva RNA levels and symptoms will be assessed at enrollment, 7 days, and 30 days post-injury. Aim 1 will assess the ability of saliva RNA to predict PPCS 30 days after mTBI (defined by reliable change index, or persistence of ≥2 symptoms on day 30, compared with pre-injury state on the Post-Concussion Symptom Inventory; PCSI). RNA accuracy will be compared to a validated clinical prediction tool (5p tool). Aim 2 will assess the ability of saliva RNA levels to identify recovered participants on day 30. RNA accuracy will be compared to change in composite score on a standardized reaction time test (from enrollment to day 30). Completion of these aims will yield an objective biologic test that can be used for prognosis at the time of mTBI, and to aid clinical decisions regarding return-to-learn or return-to-play.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of mTBI: defined by criteria from the Berlin Consensus Statement and WHO. Assessment for mTBI status be performed by a licensed clinician per the 2018 CDC guidelines.
- •Age at enrollment: 5-24 years of age (inclusive).
排除标准
- •>7d after initial mTBI
- •Glasgow Coma Scale score of 13 or less
- •Previous moderate-to-severe TBI requiring overnight hospitalization
- •Unresolved symptoms from previous concussion, or any concussion within the last 3 months
- •Abbreviated Injury Scale (AIS) score > 3 (to reduce confounding from poly-trauma)
- •Psychiatric illness requiring previous hospitalization;
- •Neurological condition (e.g. epilepsy, hydrocephalus) or abnormality on neuroimaging (if performed)
- •Intellectual disability that prevents ability to provide informed assent
- •Pregnancy
- •Active substance use/dependence
- •Previous neurosurgery
- •Non-fluency in English
- •Upper respiratory infection
- •Periodontal infection
- •Injury to the oropharynx
- •Previously enrolled in the same study
- •Inability to complete follow-up assessments
结局指标
主要结局
Presence or absence of concussion recovery 30 days after injury
时间窗: 30 days after injury
Defined as a score of 0 (no difference) on item 22 of the Post-Concussion Symptom Inventory (PCSI); "To what degree do you feel 'differently' than before your injury?" This patient-oriented outcome measure relies on the individual's experience of symptoms to define recovery.PCSI is a self reported survey that focus on symptoms in the cognitive, emotional, sleep, and physical domains. This form is called the "Sport Concussion Assessment Tool- 5th Edition" and symptoms are scored from 0 to 6 with 0 being no symptom and 6 being severe.
Presence or absence of persistent post-concussive symptoms (PPCS) 30 days after injury
时间窗: 30 days after injury
PPCS will be defined by reliable change index on day 30, compared with pre-injury state, which will be determined from pre-injury symptoms reported at enrollment using the Post-Concussion Symptom Scale (PCSS). PCSS is a self reported survey that focus on symptoms in the cognitive, emotional, sleep, and physical domains. This form is called the "Sport Concussion Assessment Tool- 5th Edition" and symptoms are scored from 0 to 6 with 0 being no symptom and 6 being severe. A high score is indicative of a subject experiencing the worst they have experienced this symptom.
次要结局
- Orientation, immediate memory, concentration, and delayed recall performance(Within 48 hours of injury)
- Balance performance(Within 48 hours of injury)
- Concussion symptom burden and severity(Within 48 hours of injury, 7 days post-injury, and 30 days post-injury)
研究者
Steven Hicks
Assistant Professor, Pediatrics
Milton S. Hershey Medical Center