Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel
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| ClinicalTrials.gov Identifier: NCT01891383 |
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Recruitment Status :
Withdrawn
(New data published showing EPO to be ineffective in TBI)
First Posted : July 3, 2013
Last Update Posted : January 18, 2019
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Sponsor:
Uniformed Services University of the Health Sciences
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences
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Brief Summary:
The objective of this study is to measure the frequency and clinical types of mild cognitive impairment (MCI) or dementia that occur among up to 150 military retirees with and without a history of traumatic brain injury (TBI) among residents of the Armed Forces Retirement Home, Washington D.C. and the Veterans Home of California-Yountville. Investigators will compare the characteristics of dementia in those who have had a prior TBI to the characteristics in those without a history of TBI. It is our hypothesis that the dementia or MCI among those with prior TBI has distinct neuropsychological features that distinguishes it from those with dementia or MCI without a history of TBI.
| Condition or disease |
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| Dementia Traumatic Brain Injury (TBI) Mild Cognitive Impairment (MCI) Chronic Traumatic Encephalopathy (CTE) Post-traumatic Stress Disorder (PTSD) |
75 participants with a history of TBI will be the cases (exposed) group. A control group of 75 retirement home residents without a history of TBI who are age-matched to the cases will also be recruited. Participants will be evaluated in a single visit, which will include neurological, psychiatric, and cognitive assessment. The evaluation will take approximately 4 hours. In some cases, the evaluation may be split into two 2 hour sessions.
| Study Type : | Observational |
| Actual Enrollment : | 0 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | Endophenotypes of Dementia Associated With Traumatic Brain Injury in Retired Military Personnel |
| Study Start Date : | July 2013 |
| Estimated Primary Completion Date : | June 2016 |
| Estimated Study Completion Date : | August 2016 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
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History of TBI
The history of TBI will be assessed by the subject's answers to the Ohio State University Traumatic Brain Injury Identification Method Short Form (OSU TBI-ID SF).
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No history of TBI
The history of TBI will be assessed by the subject's answers to the Ohio State University Traumatic Brain Injury Identification Method Short Form (OSU TBI-ID SF).
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Primary Outcome Measures :
- Prevalence of dementia or MCI in the two groups (TBI versus no TBI) [ Time Frame: Single visit, 4 hours. ]The primary outcome will be the prevalence of dementia/MCI in the two groups (i.e. those with and without a TBI).
Secondary Outcome Measures :
- Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI) [ Time Frame: Single visit, 4 hours. ]The characterization of the dementia and cognitive impairment within the two groups based on the neuropsychological testing will be secondary outcomes of the study.
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| Ages Eligible for Study: | 50 Years to 95 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Subjects for this study will be recruited from the Armed Forces Retirement Home (AFRH) in Washington, DC and the Veterans Home of California- Yountville. Up to 150 AFRH residents from both the independent living and the assisted living facilities will be invited to take the screening questionnaire and enroll in the study.
Criteria
Inclusion Criteria:
Cases (with a history of TBI):
- Ages 50-95 years
- History of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the Ohio State University TBI Identification Questionnaire—OSU TBI-ID, and based on DoD/VA criteria)
- Residence in AFRH-Washington D.C. or the Veterans Home of California-Yountville
- MMSE score ≥ 20
- Capacity to provide consent to participate in research (assessment made by study physician)
- Ability to read and write English
Controls (without a history of TBI):
- Ages 50-95 years
- No history of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the Ohio State University TBI Identification Questionnaire—OSU TBI-ID)
- Residence in AFRH-Washington or the Veterans Home of California-Yountville
- MMSE score ≥ 20
- Capacity to provide consent or assent to participate in research
- Ability to read and write English -
Exclusion Criteria:
Cases (with a history of TBI):
- History of penetrating brain injury
- History of disabling neurological or psychiatric condition such as epilepsy (besides posttraumatic epilepsy), multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia
Controls (without a history of TBI):
History of disabling neurological or psychiatric condition such as epilepsy, multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia
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): NCT01891383
Locations
| United States, California | |
| California Veterans Home-Yountville | |
| Yountville, California, United States, 94599 | |
| United States, District of Columbia | |
| Armed Forces Retirement Home | |
| Washington, District of Columbia, United States, 20011-8400 | |
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
University of California, San Francisco
Investigators
| Principal Investigator: | Ramon Diaz-Arrastia, M.D., Ph.D. | Uniformed Services University of the Health Sciences | |
| Principal Investigator: | Kristine Yaffe, MD | University of California, San Francisco |
| Responsible Party: | Ramon Diaz-Arrastia, Director of Clinical Research, Center for Neuroscience and Regenerative Medicine; Professor of Neurology, Uniformed Services University of the Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01891383 History of Changes |
| Other Study ID Numbers: |
ERMS# 12lO9006 NEU-92-1855 ( Other Identifier: USUHS ) |
| First Posted: | July 3, 2013 Key Record Dates |
| Last Update Posted: | January 18, 2019 |
| Last Verified: | January 2019 |
Keywords provided by Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences:
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Dementia Traumatic brain injury (TBI) Mild cognitive impairment (MCI) |
Chronic traumatic encephalopathy (CTE) Remote effects of TBI Post-traumatic stress disorder (PTSD_ |
Additional relevant MeSH terms:
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Wounds and Injuries Dementia Brain Injuries Cognitive Dysfunction Brain Injuries, Traumatic Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Brain Diseases Chronic Traumatic Encephalopathy Central Nervous System Diseases |
Nervous System Diseases Neurocognitive Disorders Mental Disorders Craniocerebral Trauma Trauma, Nervous System Cognition Disorders Trauma and Stressor Related Disorders Brain Injury, Chronic Neurodegenerative Diseases |