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The Use of the VOMS Tool With Military Personnel to Track mTBI Recovery and RTD Status

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02634944
Enrollment
452
Registered
2015-12-18
Start date
2018-03-16
Completion date
2020-02-29
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Traumatic Brain Injury

Keywords

Concussion, Vestibular, Ocular-Motor

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.

Interventions

DIAGNOSTIC_TESTVestibular Ocular Motor Screening Tool (VOMS)

Vestibular Ocular Motor Screening Tool (VOMS)

Sponsors

United States Department of Defense
CollaboratorFED
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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.6 monthsIn-person and telemedicine VOMS (Vestibular Ocular-Motor Screening) training with USASOC medical personnel, followed by repeated VOMS measures to examine reliability of symptom report
Change in symptoms on the VOMS at acute and sub-acute time periods correlated with recovery times to return to duty (RTD)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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026