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

NCT ID: NCT02634944

Last Updated: 2020-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2020-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Vestibular Ocular Motor Screening Tool (VOMS)

Intervention Type DIAGNOSTIC_TEST

Vestibular Ocular Motor Screening Tool (VOMS)

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.

Group Type SHAM_COMPARATOR

Vestibular Ocular Motor Screening Tool (VOMS)

Intervention Type DIAGNOSTIC_TEST

Vestibular Ocular Motor Screening Tool (VOMS)

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.

Group Type EXPERIMENTAL

Vestibular Ocular Motor Screening Tool (VOMS)

Intervention Type DIAGNOSTIC_TEST

Vestibular Ocular Motor Screening Tool (VOMS)

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.

Group Type EXPERIMENTAL

Vestibular Ocular Motor Screening Tool (VOMS)

Intervention Type DIAGNOSTIC_TEST

Vestibular Ocular Motor Screening Tool (VOMS)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vestibular Ocular Motor Screening Tool (VOMS)

Vestibular Ocular Motor Screening Tool (VOMS)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

United States Department of Defense

FED

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anthony P. Kontos, Ph.D.

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katrina Monti, PA

Role: PRINCIPAL_INVESTIGATOR

First Special Forces Group - JBLM

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

First Special Forces Group - JBLM

Fort Lewis, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25106780 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRO15090054

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Functional Vision in TBI
NCT01214070 TERMINATED PHASE4
Effectiveness of VestAid App
NCT06683417 NOT_YET_RECRUITING NA