Clinical trial NCT02634944: The Use of the VOMS Tool With Military Personnel to Track mTBI Recovery and RTD Status
Official title: The Use of the VOMS Tool With Military Personnel to Track Mild Traumatic Brain Injury Recovery and Return to Duty Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Concussion
Vestibular
Ocular-Motor
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2015-12-18
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: Change in symptoms on the VOMS at acute and sub-acute time periods correlated with recovery times to return to duty (RTD)
timeFrame: 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)
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lewis
country: United States
facility: First Special Forces Group - JBLM
state: Washington
Study officials:
affiliation: First Special Forces Group - JBLM
name: Katrina Monti, PA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mucha A, Collins MW, Elbin RJ, Furman JM, Troutman-Enseki C, DeWolf RM, Marchetti G, Kontos AP. A Brief Vestibular/Ocular Motor Screening (VOMS) assessment to evaluate concussions: preliminary findings. Am J Sports Med. 2014 Oct;42(10):2479-86. doi: 10.1177/0363546514543775. Epub 2014 Aug 8.