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

Primary Purpose

Mild Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vestibular Ocular Motor Screening Tool (VOMS)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Mild Traumatic Brain Injury focused on measuring Concussion, Vestibular, Ocular-Motor

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • First Special Forces Group - JBLM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Experimental

Arm Label

mTBI

Healthy Control

BLAST mTBI

BLUNT mTBI

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2015
Last Updated
April 3, 2020
Sponsor
University of Pittsburgh
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT02634944
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
February 29, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Concussion, Vestibular, Ocular-Motor

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
452 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mTBI
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Control
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
BLAST mTBI
Arm Type
Experimental
Arm Description
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.
Arm Title
BLUNT mTBI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Vestibular Ocular Motor Screening Tool (VOMS)
Intervention Description
Vestibular Ocular Motor Screening Tool (VOMS)
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
6 months
Title
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)
Title
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.
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrina Monti, PA
Organizational Affiliation
First Special Forces Group - JBLM
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Special Forces Group - JBLM
City
Fort Lewis
State/Province
Washington
ZIP/Postal Code
98433
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be deposited into FITBIR (Federal Interagency Traumatic Brain Injury Research)
Citations:
PubMed Identifier
25106780
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.
Results Reference
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The Use of the VOMS Tool With Military Personnel to Track mTBI Recovery and RTD Status

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