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

April 3, 2020 updated by: Anthony P. Kontos, Ph.D., University of Pittsburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

452

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Fort Lewis, Washington, United States, 98433
        • First Special Forces Group - JBLM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mTBI
mTBI (concussed) participants will be administered the VOMS after concussive event. The VOMS- which requires only a small target with 14 point font text and takes only 5 min to administer- includes assessments in five domains: (1) smooth pursuits, (2) horizontal and vertical saccades, (3) near point of convergence (NPC) distance, (4) horizontal and vertical VOR, and (5) VMS.
Diagnostic test: Vestibular Ocular Motor Screening Tool (VOMS)
Vestibular Ocular Motor Screening Tool (VOMS)
Sham Comparator: Healthy Control
Healthy controls will be administered the VOMS tool. The VOMS- which requires only a small target with 14 point font text and takes only 5 min to administer- includes assessments in five domains: (1) smooth pursuits, (2) horizontal and vertical saccades, (3) near point of convergence (NPC) distance, (4) horizontal and vertical VOR, and (5) VMS.
Diagnostic test: Vestibular Ocular Motor Screening Tool (VOMS)
Vestibular Ocular Motor Screening Tool (VOMS)
Experimental: BLAST mTBI
Blast mTBI (concussed) participants will be administered the VOMS after concussive blast event. The VOMS- which requires only a small target with 14 point font text and takes only 5 min to administer- includes assessments in five domains: (1) smooth pursuits, (2) horizontal and vertical saccades, (3) near point of convergence (NPC) distance, (4) horizontal and vertical VOR, and (5) VMS.
Diagnostic test: Vestibular Ocular Motor Screening Tool (VOMS)
Vestibular Ocular Motor Screening Tool (VOMS)
Experimental: BLUNT mTBI
Blunt mTBI (concussed) participants will be administered the VOMS after concussive blunt event. The VOMS- which requires only a small target with 14 point font text and takes only 5 min to administer- includes assessments in five domains: (1) smooth pursuits, (2) horizontal and vertical saccades, (3) near point of convergence (NPC) distance, (4) horizontal and vertical VOR, and (5) VMS.
Diagnostic test: Vestibular Ocular Motor Screening Tool (VOMS)
Vestibular Ocular Motor Screening Tool (VOMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
6 months
Change in symptoms on the VOMS at acute and sub-acute time periods correlated with recovery times to return to duty (RTD)
Time Frame: 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)
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.
Time Frame: 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 near point convergence measurements in centimeters
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Katrina Monti, PA, First Special Forces Group - JBLM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2018

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 17, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO15090054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be deposited into FITBIR (Federal Interagency Traumatic Brain Injury Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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