Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event (NKI-RIF1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Neuro Kinetics
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Neuro Kinetics
ClinicalTrials.gov Identifier:
NCT01832714
First received: April 10, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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. 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. 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.

Condition
Concussion, Mild
Concussion, Intermediate
Concussion, Severe

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event

Resource links provided by NLM:


Further study details as provided by Neuro Kinetics:

Primary Outcome Measures:
  • Variability of latency in reflexive saccades (ms) [ Time Frame: within 7 days of a concussion event ] [ Designated as safety issue: No ]
    Examine the latency of subjects with mTBI with respect to mean latency and standard deviation of control subjects.

  • Variability of latency in reaction time test (ms) [ Time Frame: within 7 days of a concussion event ] [ Designated as safety issue: No ]
    Examine the latency of subjects with mTBI with respect to mean latency and standard deviation of control subjects.

  • Variability of error in subjective visual vertical test (degrees) [ Time Frame: within 7 days of a concussion event ] [ Designated as safety issue: No ]
    Examine the mean error of subjects with mTBI with respect to mean error and standard deviation of control subjects.


Estimated Enrollment: 180
Study Start Date: September 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The study uses a prospective, between-subjects design comparing an Investigational (mTBI) Group to a Control Group. The Investigational Group includes SM who had been diagnosed with an mTBI. The Control Group consists of SM who do not have clinical symptoms consistent with mTBI. There will be 90 participants in each group, for a target total of 180 study participants

Existing mTBI evaluation tools will be used to qualify the type and severity of a patient's mTBI symptoms. After the volunteer has been assessed by a physician, the following questionnaires and screening tools will be administered:

  • Demographic, included control and patient demographics, education, military service, see Appendix A;
  • History of health problems and treatments included medication and mTBI history and stress level before testing, including page 1 of MACE, see Appendix B; History of health problems and treatments included medication and mTBI history and stress level before testing, including page 1 of MACE, used for seconds and third tests only, see Appendix B1;
  • Glasgow Coma Scale, use only in 24 hrs after accident, see Appendix C;
  • Functional Gait Assessment(FGA) - This is an assessment where the individual is asked to perform ten gait tasks. Each gait task is scored by a trained observer on a 0-3 scale (with 0 being could not perform and 3 being performed well). The individual will end up with a total FGA of between 0-30. The test is very sensitive for demonstrating balance dysfunction and improvement.(see Appendix D)
  • Trail Making Test (TMT) - This test is a cognitive test in which subjects use a pencil to draw a line between an ordered series of letters or letters/numbers on a paper. Subjects are instructed to follow the appropriate order without lifting the pencil from the paper. Time to completion is a sensitive measure of cognitive performance. (see Appendix E)
  • Dizziness Handicap Inventory,(DHI)-This validated questionnaire is commonly used by clinicians to qualify and quantify symptoms associated with dizziness, light-headedness, vertigo, migraine associated dizziness, and to assist with identifying complaints of dizziness related to anxiety, depression, post-traumatic-stress disorder, etc. This tool will capture subjective symptoms associated with mTBI prior to completing the objective measures (see Appendix F)

Device will be comprehensive oculomotor/ neuro-otologic testing system. System components:

  • Motorized Chair that can move in up to 3 axis
  • Full field Optokinetic stimulus
  • Pursuit Tracker™ - laser target generator
  • Isolation enclosure
  • Patient monitoring and communication technology

FDA classification: The NOTC is covered under an FDA 510K, and certified to standards 60601-1, 60601-1-1, 60601-1-2, and 60601-1-4.

Modifications to approved device:

Included by manufacturer:

  1. A new function to existing buttons for reaction time test
  2. Audio stimulus for audio reaction time test
  3. 2 stationary LED's installed inside enclosure ceiling for crHIT test

Investigational software which incorporates newly defined oculomotor and reaction time tests designed to investigate mTBI will be installed on the device.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion criteria for all subjects (Control and mTBI) - Males or females from 19 - 45years of age and of all races.

Additional Inclusion criteria for mTBI Subjects

- Diagnosed with traumatic brain injury utilizing 2007 DoD Standard diagnosis of

  • 1) Exposed to an event,
  • 2) Suffered alteration or loss of consciousness secondary to the event, and
  • 3) Had a sequelae from the event.

Exclusion criteria for all subjects (Control and mTBI)

  • 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.
  • Medications which depress the sensorium precluding patient compliance with the testing (considered on a case-by-case basis)
  • Previous contraindicating surgeries at the discretion of the study physicians or audiologists

Additional Exclusion criteria for Control Subjects

  • Concussion within the last year (12 months)
  • Repeated blast exposure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832714

Contacts
Contact: Alex Kiderman, PhD ME 4129636649 akiderman@neuro-kinetics.com
Contact: Dan Sweeney, BS 4129636649 dsweeney@neuro-kinetics.com

Locations
United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Michael E Hoffer, MD    619-532-6820    Michael.Hoffer@med.navy.mil   
Contact: Sara Murphy, MPH    619-532-6820    Sara.Murphy.ctr@med.navy.mil   
Principal Investigator: Michael E Hoffer, MD         
United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431
Contact: James V Crawford, MD    253-968-1420    james.v.crawford.mil@mail.mil   
Contact: Kate Marshall, PhD    360-775-5144    kathryn.e.marshall2.ctr@mail.mil   
Principal Investigator: James V Crawford, MD         
Sponsors and Collaborators
Neuro Kinetics
Investigators
Principal Investigator: Alex Kiderman, PhD ME Neuro Kinetics, Inc
  More Information

No publications provided

Responsible Party: Neuro Kinetics
ClinicalTrials.gov Identifier: NCT01832714     History of Changes
Other Study ID Numbers: NKI-W81XWH-12-C-0205
Study First Received: April 10, 2013
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Neuro Kinetics:
Concussion
mTBI
military
MACE
NKI
NOTC
VNG
VOG
Neuro Kinetics
oculomotor
vestibular
reaction time
I-Portal
eye tracking
Dizziness Handicap Inventory

Additional relevant MeSH terms:
Brain Concussion
Brain Diseases
Brain Injuries
Central Nervous System Diseases
Craniocerebral Trauma
Head Injuries, Closed
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on October 22, 2014