Mild Traumatic Brain Injury Discrimination
- Conditions
- Brain Concussion
- Interventions
- Device: Multi-modal assessment system
- Registration Number
- NCT02453958
- Lead Sponsor
- Empirical Technologies Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- Military personnel
- Age 18 to 45
- Diagnosis of mTBI within past 5 years
- Rancho Los Amigos Scale score of 7 or above
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mTBI-diagnosed group Multi-modal assessment system Subjects diagnosed with mTBI were assessed with a multi-modal assessment system. non mTBI-diagnosed group Multi-modal assessment system Non-concussed subjects were assessed with a multi-modal assessment system.
- Primary Outcome Measures
Name Time Method Receiver-operator-curve area under the curve (AUC) up to 5 years Each test's discrimination capability was quantified using AUC and p value
- Secondary Outcome Measures
Name Time Method