Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel

NCT ID: NCT01891383

Last Updated: 2019-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dementia Traumatic Brain Injury (TBI) Mild Cognitive Impairment (MCI) Chronic Traumatic Encephalopathy (CTE) Post-traumatic Stress Disorder (PTSD)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Cases (with a history of TBI):

1. Ages 50-95 years
2. 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)
3. Residence in AFRH-Washington D.C. or the Veterans Home of California-Yountville
4. MMSE score ≥ 20
5. Capacity to provide consent to participate in research (assessment made by study physician)
6. Ability to read and write English

Controls (without a history of TBI):

1. Ages 50-95 years
2. 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)
3. Residence in AFRH-Washington or the Veterans Home of California-Yountville
4. MMSE score ≥ 20
5. Capacity to provide consent or assent to participate in research
6. Ability to read and write English -

Exclusion Criteria

Cases (with a history of TBI):

1. History of penetrating brain injury
2. 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

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Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role lead

Responsible Party

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Ramon Diaz-Arrastia

Director of Clinical Research, Center for Neuroscience and Regenerative Medicine; Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramon Diaz-Arrastia, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Kristine Yaffe, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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California Veterans Home-Yountville

Yountville, California, United States

Site Status

Armed Forces Retirement Home

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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ERMS# 12lO9006

Identifier Type: -

Identifier Source: org_study_id

NEU-92-1855

Identifier Type: OTHER

Identifier Source: secondary_id

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