Mild Traumatic Brain Injury Discrimination

NCT ID: NCT02453958

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-01-31

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.

Conditions

Brain Concussion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

mTBI-diagnosed group

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

Group Type: EXPERIMENTAL

Multi-modal assessment system

Intervention Type: DEVICE

Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests

non mTBI-diagnosed group

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

Group Type: EXPERIMENTAL

Multi-modal assessment system

Intervention Type: DEVICE

Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests

Interventions

Multi-modal assessment system

Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role: collaborator

Walter Reed Army Medical Center

FED

Sponsor Role: collaborator

Empirical Technologies Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin C. Baruch, PhD

Role: PRINCIPAL_INVESTIGATOR

Empirical Technologies Corporation

Other Identifiers

ETC_mTBI_001

Identifier Type: -

Identifier Source: org_study_id