Clinical Trial: Mild Traumatic Brain Injury Discrimination

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Non-Invasive Assay to Discriminate 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 Summary: 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.
Sponsor: Empirical Technologies Corporation

Current Primary Outcome: Receiver-operator-curve area under the curve (AUC) [ Time Frame: up to 5 years ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Empirical Technologies Corporation

Dates:
Date Received: May 20, 2015
Date Started: June 2011
Date Completion:
Last Updated: May 21, 2015
Last Verified: May 2015