Mild Traumatic Brain Injury Discrimination

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury

Conditions
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Brain Concussion

Intervention / Treatment
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* Device: Multi-modal assessment system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mTBI-diagnosed group<br>Subjects diagnosed with mTBI were assessed with a multi-modal assessment system. | Device: Multi-modal assessment system<br>* Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests<br>|
| Experimental: non mTBI-diagnosed group<br>Non-concussed subjects were assessed with a multi-modal assessment system. | Device: Multi-modal assessment system<br>* Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receiver-operator-curve area under the curve (AUC) | Each test's discrimination capability was quantified using AUC and p value | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injury, Brain, Traumatic Mild, Mild Traumatic Brain Injury