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Genotype Influence on Recovery After Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00018499
Recruitment Status : Completed
First Posted : July 5, 2001
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
VA Office of Research and Development

Brief Summary:
Genetic differences in response to brain injury may reasonably be expected to play a role in the initial consequences of traumatic brain injury and in the rate of recovery from such injury.

Condition or disease
Brain Injury

Detailed Description:
Polymorphisms in the Apolipoprotein E gene encode functional variants which differentially determine the rate at which neuronal repair can occur, and are associated with differences in expression of neurodegenerative processes, including traumatic brain injury. It is proposed that the accuracy of prediction of outcome after head injury will be significantly increased by inclusion of APOE genotype alone, or in combination with other variables such as severity of head injury, cognitive, electroencephalographic or neuroradiologic measures, or treatment strategies.

Study Type : Observational
Official Title: The Influence of APOE Genotype on Recovery After Traumatic Brain Injury
Study Start Date : October 1998
Estimated Study Completion Date : October 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patients enrolled in the DVHIP are subject to the following recruitment criteria:

  1. Mild, moderate or severe closed head injury, where the cut off between mild and moderate is defined by GCS<12. PTA>24 hrs or - foca cerebral contusion on CT/MRI or Loss of Consciousness (LOC) > 12 hours.

    Note: the definition of mild, moderate or severe head injury differs widely between centers and is absolutely not critical for the work proposed as we will use continuous measures of severity throughout.

  2. Within three months of first assessment. (In practice, patients may be recruited after 3 months. We will deal with this issue by covarying the time from injury to first assessment in our analyses).
  3. Rancho Los Amigos cognitive level of 5-7 at first assessment.
  4. Volunteer informed consent signed by patient of family.
  5. Military or veterans health care beneficiary.
  6. Age 17-55

Exclusion Criteria:

  1. Unwillingness to participate in rehabilitation program or cooperate with investigators.
  2. History of prior severe traumatic brain injury of other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00018499


Locations
United States, Florida
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33612
Sponsors and Collaborators
VA Office of Research and Development
Investigators
OverallOfficial: Fiona Crawford, Ph.D.
OverallOfficial: Rodney Vanderploeg, Ph.D.
OverallOfficial: Robert Thatcher, Ph.D.
OverallOfficial: Andres Salazar, M.D.

ClinicalTrials.gov Identifier: NCT00018499     History of Changes
Other Study ID Numbers: EPID-030-98S
First Posted: July 5, 2001    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: December 2004

Keywords provided by VA Office of Research and Development:
Traumatic Brain Injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System