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Mild Traumatic Brain Injury Discrimination (MTBID)

Primary Purpose

Brain Concussion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multi-modal assessment system
Sponsored by
Empirical Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Concussion focused on measuring Injury, Brain, Traumatic Mild, Mild Traumatic Brain Injury

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    mTBI-diagnosed group

    non mTBI-diagnosed group

    Arm Description

    Subjects diagnosed with mTBI were assessed with a multi-modal assessment system.

    Non-concussed subjects were assessed with a multi-modal assessment system.

    Outcomes

    Primary Outcome Measures

    Receiver-operator-curve area under the curve (AUC)
    Each test's discrimination capability was quantified using AUC and p value

    Secondary Outcome Measures

    Full Information

    First Posted
    May 20, 2015
    Last Updated
    May 21, 2015
    Sponsor
    Empirical Technologies Corporation
    Collaborators
    Hunter Holmes Mcguire Veteran Affairs Medical Center, Walter Reed Army Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02453958
    Brief Title
    Mild Traumatic Brain Injury Discrimination
    Acronym
    MTBID
    Official Title
    Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Empirical Technologies Corporation
    Collaborators
    Hunter Holmes Mcguire Veteran Affairs Medical Center, Walter Reed Army Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Concussion
    Keywords
    Injury, Brain, Traumatic Mild, Mild Traumatic Brain Injury

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    mTBI-diagnosed group
    Arm Type
    Experimental
    Arm Description
    Subjects diagnosed with mTBI were assessed with a multi-modal assessment system.
    Arm Title
    non mTBI-diagnosed group
    Arm Type
    Experimental
    Arm Description
    Non-concussed subjects were assessed with a multi-modal assessment system.
    Intervention Type
    Device
    Intervention Name(s)
    Multi-modal assessment system
    Intervention Description
    Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests
    Primary Outcome Measure Information:
    Title
    Receiver-operator-curve area under the curve (AUC)
    Description
    Each test's discrimination capability was quantified using AUC and p value
    Time Frame
    up to 5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martin C. Baruch, PhD
    Organizational Affiliation
    Empirical Technologies Corporation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Mild Traumatic Brain Injury Discrimination

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