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临床试验/NCT02901821
NCT02901821进行中(未招募)不适用

Predicting Concussion Outcomes With Salivary miRNA

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
700
试验地点
2
主要终点
Presence or absence of concussion symptoms

研究概览

简要总结

The purpose of this study is to identify changes in salivary ribosomal nucleic acid (RNA) expression that are predictive of symptom duration and character following mild traumatic brain injury (mTBI) in children.

详细描述

The purpose of this study is to characterize longitudinal salivary RNA expression in 600 children with mTBI and identify RNA patterns that predict length and characterof concussive symptoms, as well as the response to therapy.

Hypothesis

Specific RNAs will be differentially regulated in children with prolonged mTBI symptoms across the acute and sub-acute time periods. The investigators predict that a set of RNAs with differential expression in children with mTBI will be statistically associated with functional measures of mTBI symptoms as well as the duration of concussive symptoms.

Rationale: Preliminary studies show that miRNA is altered in adults with varying degrees of TBI and that salivary RNA is altered by disorders of the CNS. These studies indicate that serum-based miRNA may be used as an accurate biomarker for differentiating adults with and without TBI. Whether similar patterns can seen in the saliva of children following mTBI remains to be seen. Furthermore, the influence of confounding variables such as gender, mechanism of injury, and previous mTBIs on RNA profiles has not been explored. The investigators propose to investigate these questions by examining salivary RNA from 600 children (ages five to twenty-one years) with a clinical diagnosis of mTBI (as well as 100 age-and gender-matched controls, recruited from the Penn State Pediatric Concussion Clinic, Emergency Department, and the affiliated primary care clinics). The investigators plan to prospectively follow 600 children with mTBI for 1-month post-concussion, tracking subjective symptoms with the Child Sports Concussion Assessment Tool (SCAT-5), and objective symptoms of balance and cognition. Saliva will be collected via swab at three time-points (at initial clinical presentation, 1-2 weeks, and 4-weeks after the date of initial mTBI). Expression of salivary RNA taken at initial presentation will be compared against symptom duration (where prolonged post-concussive symptoms are defined as those lasting >4 weeks) and character (as measured numerically by Post-concussion symptom inventory self-report and ClearEdge scoring). The investigators plan to identify a set of salivary RNAs that can easily be used to predict clinical course for pediatric patients following a diagnosis of mTBI.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
5 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 5-21 years with mild traumatic brain injury that occurred within 7 days of enrollment

排除标准

  • Sever traumatic brain injury
  • Skull fracture
  • Concurrent upper respiratory infection
  • Patients whose primary language is not English
  • Periodontal infection
  • Wards of the state
  • Ongoing seizure disorder,
  • Drug or alcohol dependency

研究组 & 干预措施

Control

No intervention. Collection of medical/demographic info and salivary RNA in children 5-21 years without history of mild traumatic brain injury (mTBI).

干预措施: salivary RNA collection (Genetic)

Concussion

Collection of medical/demographic info and salivary RNA in children 5-21 years with history of mild traumatic brain injury (mTBI). Collection of PCSI concussion assessment interview tool and balance/cognition testing at time of injury, 1-2wks post injury, and 4wks post injury.

干预措施: salivary RNA collection (Genetic)

结局指标

主要结局

Presence or absence of concussion symptoms

时间窗: 4-weeks post injury

subjective (score \>7 on PCSI) or objective (score outside 85 percentile on accelerometer balance testing or cognitive testing)

次要结局

  • Salivary RNA profile(Within 7d of initial injury, 1-2 weeks post-injury, and 4-weeks post-injury)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Hicks

Assistant Professor of Pediatrics

Milton S. Hershey Medical Center

研究点 (2)

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