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Mild Traumatic Brain Injury Discrimination

Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02453958
Acronym
MTBID
Enrollment
56
Registered
2015-05-27
Start date
2011-06-30
Completion date
2013-01-31
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Concussion

Keywords

Injury, Brain, Traumatic Mild, Mild Traumatic Brain Injury

Brief 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.

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.

Interventions

DEVICEMulti-modal assessment system

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

Sponsors

Hunter Holmes Mcguire Veteran Affairs Medical Center
CollaboratorFED
Walter Reed Army Medical Center
CollaboratorFED
Empirical Technologies Corporation
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Receiver-operator-curve area under the curve (AUC)up to 5 yearsEach test's discrimination capability was quantified using AUC and p value

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026