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Eye Movement Recordings in the Diagnosis of Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00875589
First received: April 1, 2009
Last updated: October 15, 2015
Last verified: October 2015
Results First Received: September 10, 2015  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Traumatic Brain Injury

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Controls Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
MTBI MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)

Participant Flow:   Overall Study
    Controls   MTBI
STARTED   15   11 
COMPLETED   15   11 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Controls Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
MTBI MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
Total Total of all reporting groups

Baseline Measures
   Controls   MTBI   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   11   26 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   15   11   26 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   8   2   10 
Male   7   9   16 


  Outcome Measures

1.  Primary:   Stability of Fixation   [ Time Frame: During eye movement recording session (20 sec). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jonathan Jacobs, PhD
Organization: Daroff-Dell'Osso Ocular Motility Laboratory
phone: 216-791-3800 ext 2947
e-mail: jxj24@case.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00875589     History of Changes
Other Study ID Numbers: B6403-R
Study First Received: April 1, 2009
Results First Received: September 10, 2015
Last Updated: October 15, 2015
Health Authority: United States: Federal Government