NCT02453958

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

May 20, 2015

Last Update Submit

May 21, 2015

Conditions

Brain Concussion

Keywords

InjuryBrainTraumatic MildMild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Receiver-operator-curve area under the curve (AUC)

    Each test's discrimination capability was quantified using AUC and p value

    up to 5 years

Study Arms (2)

mTBI-diagnosed group

EXPERIMENTAL

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

Device: Multi-modal assessment system

non mTBI-diagnosed group

EXPERIMENTAL

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

Device: Multi-modal assessment system

Interventions

Multi-modal assessment systemDEVICE

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

mTBI-diagnosed groupnon mTBI-diagnosed group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Military personnel
  • Age 18 to 45
  • Diagnosis of mTBI within past 5 years
  • Rancho Los Amigos Scale score of 7 or above

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain ConcussionWounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Martin C. Baruch, PhD

    Empirical Technologies Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 27, 2015

Study Start

June 1, 2011

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

May 27, 2015

Record last verified: 2015-05