NCT02634944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
2.2 years until next milestone

Study Start

First participant enrolled

March 16, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

December 3, 2015

Last Update Submit

April 3, 2020

Conditions

Mild Traumatic Brain Injury

Keywords

ConcussionVestibularOcular-Motor

Outcome Measures

Primary Outcomes (3)

  • 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

    6 months

  • 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)

  • 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

    6 months

Study Arms (4)

mTBI

EXPERIMENTAL

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)

Healthy Control

SHAM COMPARATOR

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)

BLAST mTBI

EXPERIMENTAL

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)

BLUNT mTBI

EXPERIMENTAL

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)

Interventions

Vestibular Ocular Motor Screening Tool (VOMS)DIAGNOSTIC_TEST

Vestibular Ocular Motor Screening Tool (VOMS)

BLAST mTBIBLUNT mTBIHealthy ControlmTBI

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Special Forces Group - JBLM

Fort Lewis, Washington, 98433, United States

Location

Related Publications (1)

  • 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.

    PMID: 25106780BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Katrina Monti, PA

    First Special Forces Group - JBLM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 18, 2015

Study Start

March 16, 2018

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

April 6, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

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

Locations

US(1)