Mild Traumatic Brain Injury Discrimination (MTBID)

May 21, 2015 updated by: Empirical Technologies Corporation

Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury

Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mTBI-diagnosed group
Subjects diagnosed with mTBI were assessed with a multi-modal assessment system.
Device: Multi-modal assessment system
Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests
Experimental: non mTBI-diagnosed group
Non-concussed subjects were assessed with a multi-modal assessment system.
Device: Multi-modal assessment system
Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Empirical Technologies Corporation

Collaborators

Walter Reed Army Medical Center
Hunter Holmes Mcguire Veteran Affairs Medical Center

Investigators

  • Principal Investigator: Martin C. Baruch, PhD, Empirical Technologies Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETC_mTBI_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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