Skip to main content
Clinical Trials/NCT02453958
NCT02453958
Completed
Not Applicable

Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury

Empirical Technologies Corporation0 sites56 target enrollmentJune 2011

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
January 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Empirical Technologies Corporation
Responsible Party
Sponsor

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

Similar Trials