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Genotype Influence on Recovery After Traumatic Brain Injury

Primary Purpose

Brain Injury

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Brain Injury focused on measuring Traumatic Brain Injury

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Patients enrolled in the DVHIP are subject to the following recruitment criteria: 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. 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). Rancho Los Amigos cognitive level of 5-7 at first assessment. Volunteer informed consent signed by patient of family. Military or veterans health care beneficiary. Age 17-55 Exclusion Criteria: Unwillingness to participate in rehabilitation program or cooperate with investigators. History of prior severe traumatic brain injury of other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.

Sites / Locations

  • James A. Haley Veterans' Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 3, 2001
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00018499
Brief Title
Genotype Influence on Recovery After Traumatic Brain Injury
Official Title
The Influence of APOE Genotype on Recovery After Traumatic Brain Injury
Study Type
Observational

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
Traumatic Brain Injury

7. Study Design

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients enrolled in the DVHIP are subject to the following recruitment criteria: 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. 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). Rancho Los Amigos cognitive level of 5-7 at first assessment. Volunteer informed consent signed by patient of family. Military or veterans health care beneficiary. Age 17-55 Exclusion Criteria: Unwillingness to participate in rehabilitation program or cooperate with investigators. History of prior severe traumatic brain injury of other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiona Crawford, Ph.D.
First Name & Middle Initial & Last Name & Degree
Rodney Vanderploeg, Ph.D.
First Name & Middle Initial & Last Name & Degree
Robert Thatcher, Ph.D.
First Name & Middle Initial & Last Name & Degree
Andres Salazar, M.D.
Facility Information:
Facility Name
James A. Haley Veterans' Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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Genotype Influence on Recovery After Traumatic Brain Injury

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