跳至主要内容
临床试验/NCT02634944
NCT02634944已完成不适用

The Use of the VOMS Tool With Military Personnel to Track Mild Traumatic Brain Injury Recovery and Return to Duty Status

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 452 人开始时间: 2018年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
452
试验地点
2
主要终点
Change in symptoms on the VOMS at acute and sub-acute time periods correlated with recovery times to return to duty (RTD)

研究概览

简要总结

The purpose of the proposed project is to determine if the VOMS is an effective screening tool to identify and track recovery of vestibular and ocular motor impairment and symptoms following mTBI, that corpsman-level medical personnel can successfully implement in combat and non-combat environments. A second purpose of the project is to determine if impairment and symptoms on the VOMS is more pronounced following blast compared to blunt mTBI.

详细描述

Vestibular impairment and symptoms are prevalent following mild traumatic brain injury (mTBI) and may play a role in prolonged recovery. Researchers have indicated that ocular motor dysfunction and symptoms are common among personnel exposed to blast mTBI. In fact, researchers have suggested that vestibular and ocular motor outcomes such as VOR and vestibulo-spinal reflex (VSR) may be useful in identifying the effects of blast from blunt mTBI. There are currently no brief, clinical screening tools to identify vestibular/ocular motor impairment and symptoms in military personnel following mTBI. Our research team recently developed the Vestibular/Ocular Motor Screening (VOMS) tool to screen for vestibular/ocular motor impairment and symptoms following mTBI. Our preliminary research indicates that VOMS- a 5-min clinical screening tool that can be deployed by corpsman-level (i.e., Special Operation Combat Medics [SOCM], Special Forces Medical Sergeants [18D]) medical personnel with minimal training and materials- was nearly 90% accurate in identifying patients with mTBI from healthy controls. These preliminary findings suggest that VOMS may augment current clinical screening tools- such as the MACE- used by the U.S. Military. The proposed project addresses the "studies to develop standardized metrics for vestibular assessment and monitoring for return to duty" area in the Diagnostics subsection of the Hearing Loss/Dysfunction, Balance Disorder, and or Tinnitus section under the Clinical Trial Research Focus Area.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All Participants:
  • Military personnel;
  • Age 18-40 years;
  • Normal or corrected normal vision
  • mTBI Participants:
  • Diagnosed with mTBI (blast, blunt, or combo) within past 7 days
  • Clear mechanism of injury
  • Glasgow Coma Scale (GCS) = 13-15
  • Reported or observed signs (Loss of consciousness [LOC], amnesia, disorientation/confusion) at time of injury
  • Current reported symptoms and/or impairment (cognitive, balance, visual)

排除标准

  • History of vestibular disorder;
  • History of neurological disorder;
  • History of previous moderate to severe TBI

结局指标

主要结局

Change in symptoms on the VOMS at acute and sub-acute time periods correlated with recovery times to return to duty (RTD)

时间窗: 3 time periods: 1-7 days post injury; 8 days to 3 months post injury; return to duty (RTD-time period is variable because it is based on individual recovery-assessed up to 36 months)

Reliability of US military corpsmen-level medical personnel (i.e., Special Operation Combat Medics [SOCM], Special Forces Medical Sergeants [18D]) to administer the VOMS to US military personnel in combat and non-combat environments.

时间窗: 6 months

In-person and telemedicine VOMS (Vestibular Ocular-Motor Screening) training with USASOC medical personnel, followed by repeated VOMS measures to examine reliability of symptom report

次要结局

未报告次要终点

研究者

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

Anthony P. Kontos, Ph.D.

PhD

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验