NCT01832714

Brief Summary

This study is designed to evaluate the use of a collection of tests that measure the eye response, balance, oculomotor and reaction time tests to aid in the diagnosis of mTBI. The tests use highly precise measurement tools to assess various neurologic functions. (For example, high-speed cameras to record eye movement, high-end motors to precisely spin and move the subject, comprehensive analysis to stitch together the stimulus and the response.) Hypotheses:

  1. 1.A battery of oculomotor, vestibular and reaction time tests will generate variables that when properly weighted and run through a given multi-variant analysis, will separate the subjects into one of two groups, mTBI or not-mTBI.
  2. 2.A battery of neurologic assessment tests including reaction time, vestibular and oculomotor tests taxing a range of neurologic functions and executed using one or more of the I-Portal® family of devices, will generate responses that, when used by a trained physician, can aid in the diagnosis of an mTBI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

April 10, 2013

Last Update Submit

July 16, 2019

Conditions

Concussion, MildConcussion, IntermediateConcussion, Severe

Keywords

ConcussionmTBImilitaryMACENKINOTCVNGVOGNeuro Kineticsoculomotorvestibularreaction timeI-Portaleye trackingDizziness Handicap Inventory

Outcome Measures

Primary Outcomes (3)

  • Variability of latency in reflexive saccades (ms)

    Examine the latency of subjects with mTBI with respect to mean latency and standard deviation of control subjects.

    within 7 days of a concussion event

  • Variability of latency in reaction time test (ms)

    Examine the latency of subjects with mTBI with respect to mean latency and standard deviation of control subjects.

    within 7 days of a concussion event

  • Variability of error in subjective visual vertical test (degrees)

    Examine the mean error of subjects with mTBI with respect to mean error and standard deviation of control subjects.

    within 7 days of a concussion event

Study Arms (2)

mTBI

Subjects who undergo an mTBI event

Control

Subjects who do not undergo an mTBI

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The Investigational Group includes Service Members (SM) and civilians who had been diagnosed with an mTBI. The Control Group consists of SM and civilians who do not have clinical symptoms consistent with mTBI. There will be at least 90 participants in each group, for a target total of at least 180 study participants.

You may qualify if:

  • \- Diagnosed with traumatic brain injury utilizing 2007 DoD Standard diagnosis of
  • \) Exposed to an event,
  • \) Suffered alteration or loss of consciousness secondary to the event, and
  • \) Had a sequelae from the event.

You may not qualify if:

  • Brain injury resulting from a penetrating wound to the head, neck, face or brain (to include gunshot wounds)
  • Presence of severe aphasia
  • Persons whom have had an mTBI within the prior month and are symptomatic.
  • Persons with a previous history of multiple mTBIs and are symptomatic.
  • History of neuropsychiatric disorders antedating the head injury (e.g. hypochondriasis, major depression, schizophrenia)
  • Pregnancy
  • Prior disorders of hearing and balance including:
  • Meniere's disease
  • Chronic migraine
  • Multiple sclerosis
  • Vestibular neuritis
  • Vestibular schwannoma
  • Sudden sensorineural hearing loss
  • Cerebrovascular disorders
  • Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

  • Alex Kiderman, PhD ME

    Neuro Kinetics, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 16, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

November 1, 2015

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations

US(2)