Mild Traumatic Brain Injury Discrimination (MTBID)

Empirical Technologies

Status: Completed

Conditions: Brain Concussion

Treatments: Device: Multi-modal assessment system

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02453958

ETC_mTBI_001

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

mTBI-diagnosed group

Experimental group

Description:

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

Treatment:

Device: Multi-modal assessment system

non mTBI-diagnosed group

Experimental group

Description:

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

Treatment:

Device: Multi-modal assessment system