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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634944
• Other study ID #: PRO15090054
• Status: Completed
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: April 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Diagnostic Test:
• Vestibular Ocular Motor Screening Tool (VOMS)
Vestibular Ocular Motor Screening Tool (VOMS)

Locations

Country	Name	City	State
United States	First Special Forces Group - JBLM	Fort Lewis	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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