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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 17, 2005 | ||||||||
| Last Updated Date | December 29, 2008 | ||||||||
| Start Date ICMJE | April 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00132249 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Vietnam Head Injury Study - Phase III | ||||||||
| Official Title ICMJE | A 30 Year Post-Injury Follow-Up Study of Vietnam Veterans Who Sustained Traumatic Brain Injury While in Combat. | ||||||||
| Brief Summary | The Vietnam Head Injury Study (VHIS)-Phase III is a prospective, long-term follow-up study of head-injured Vietnam veterans. The purpose of this research study is to determine the long-term consequences, if any, of head injury. |
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| Detailed Description | The VHIS - Phase III evaluation to be conducted approximately 30 years post-injury will be devoted to examining, cutting-edge cognitive neuroscience issues and will utilize state of the art technologies to address basic research questions in the following areas: (1) Functions of the human prefrontal cortex; (2) Cognitive neuroplasticity in the aging brain; (3) Memory; (4) Long-term behavioral and psychosocial outcome; and (5) Neurological studies, including an evaluation of post-traumatic epilepsy and repeat clinical measures from Phase - II. This testing will be complemented with structural neuroimaging, electroencephalogram (EEG) and molecular genetics. The goals of the VHIS - Phase III include providing clinicians and scientists new insights into the long term recovery of function following brain injury, the role of the prefrontal cortex in executive functions, better predictors of long term outcome (including cognitive, neurological, and genetic factors), and the effects of head injury incurred in youth on aging and the development of dementia. |
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| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Other | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 254 | ||||||||
| Completion Date | September 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | The researchers are seeking healthy CONTROL participants. Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00132249 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | DAMD17-01-1-0675, NNMC IRB ID# B03-043 | ||||||||
| Study Sponsor ICMJE | U.S. Army Medical Research and Materiel Command | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | U.S. Army Medical Research and Materiel Command | ||||||||
| Verification Date | September 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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