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CompletedNCT02453958MTBIDUpdated May 27, 2015

Mild Traumatic Brain Injury Discrimination

An interventional study of Multi-modal assessment system in Brain Concussion, sponsored by Empirical Technologies Corporation. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-27.

Sponsored by Empirical Technologies Corporation · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.

Read the detailed description

This was a preliminary validational study of a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests on a new hardware platform, the Computerized Brain Injury Assessment System (CBIAS). Using receiver operator curve (ROC) analyses, 1) a subset of the most discriminating neuro-physiological assessment tests involving smooth pursuit eye motion (SPEM) tracking errors, corrective saccade counts, a balance score ratio sensitive to vestibular balance performance and two neurocognitive tests of response speed and memory/incidental learning, was identified, 2) the enhancement in discriminatory capability of detecting concussion-related deficits through the combination of the identified subset of assessments was demonstrated, and 3) the effectiveness of a robust and readily implemented global scoring approach was demonstrated for both eye track and balance assessment tests. These results are significant in introducing a comprehensive solution for concussion assessment that incorporates an economical, compact and mobile hardware system and an assessment battery that is multi-modal, time efficient and whose efficacy has been demonstrated on a preliminary basis. This represents a significant step toward the goal of a system capable of making a dependable return-to-play/duty determination based on concussion likelihood.

02

Conditions studied

  • Brain Concussion

Keywords

  • Injury
  • Brain
  • Traumatic Mild
  • Mild Traumatic Brain Injury
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 56 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Empirical Technologies Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Military personnel
  • Age 18 to 45
  • Diagnosis of mTBI within past 5 years
  • Rancho Los Amigos Scale score of 7 or above

Exclusion criteria

Exclusion Criteria:

  • Non-military individuals
  • Below age 18 or older than 45
  • No diagnosis of mTBI within past 5 years
  • Rancho Los Amigos Scale score of 6 or below
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    mTBI-diagnosed group

    Subjects diagnosed with mTBI were assessed with a multi-modal assessment system.

    Device: Multi-modal assessment system

  • Experimental
    non mTBI-diagnosed group

    Non-concussed subjects were assessed with a multi-modal assessment system.

    Device: Multi-modal assessment system

Interventions

  • DeviceMulti-modal assessment system

    Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests

06

What researchers measure

Primary outcomes

  1. Receiver-operator-curve area under the curve (AUC)

    Each test's discrimination capability was quantified using AUC and p value

    Time frame: up to 5 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02453958
Lead sponsor
Empirical Technologies Corporation
Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center, Walter Reed Army Medical Center
Responsible party
Sponsor
First posted
May 27, 2015
Start date
Jun 2011
Primary completion
Dec 2012
Completion
Jan 2013
Last update
May 27, 2015

Study contacts

Martin C. Baruch, PhD
principal investigator · Empirical Technologies Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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