NCT02453958

Mild Traumatic Brain Injury Discrimination

Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Empirical Technologies Corporation · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Brain Concussion

Interventions

Type	Name	Description
DEVICE	Multi-modal assessment system	Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2015-05-27
• Last updated: 2015-05-27