Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Concussion
- Sponsor
- Empirical Technologies Corporation
- Enrollment
- 56
- Primary Endpoint
- Receiver-operator-curve area under the curve (AUC)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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