Mild Traumatic Brain Injury Discrimination

Brain Concussion Clinical Trial

— MTBID  

Official title:

Non-Invasive Assay to Discriminate Mild Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453958
• Other study ID #: ETC_mTBI_001
• Status: Completed
• Phase: N/A
• First received: May 20, 2015
• Last updated: May 21, 2015
• Start date: June 2011
• Est. completion date: January 2013

Study information

• Verified date: May 2015
• Source: Empirical Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries

Intervention

Device:
• Multi-modal assessment system
Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Empirical Technologies Corporation	Hunter Holmes Mcguire Veteran Affairs Medical Center, Walter Reed Army Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Receiver-operator-curve area under the curve (AUC)	Each test's discrimination capability was quantified using AUC and p value	up to 5 years	No