Genotype Influence on Recovery After Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018499
First received: July 3, 2001
Last updated: January 20, 2009
Last verified: December 2004
  Purpose

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
Brain Injury

Study Type: Observational
Official Title: The Influence of APOE Genotype on Recovery After Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Study Start Date: October 1998
Estimated Study Completion Date: October 2001
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.

  Eligibility

Ages Eligible for Study:   17 Years to 55 Years
Genders Eligible for Study:   Both
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.
  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: NCT00018499

Locations
United States, Florida
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Investigators
Investigator: Fiona Crawford, Ph.D.
Investigator: Rodney Vanderploeg, Ph.D.
Investigator: Robert Thatcher, Ph.D.
Investigator: Andres Salazar, M.D.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00018499     History of Changes
Other Study ID Numbers: EPID-030-98S
Study First Received: July 3, 2001
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Traumatic Brain Injury

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

ClinicalTrials.gov processed this record on September 18, 2014