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
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
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
NCT ID
NCT02453958
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
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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