Clinical trial NCT01891383: Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel
Official title: Endophenotypes of Dementia Associated With Traumatic Brain Injury in Retired Military Personnel
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Dementia
Traumatic Brain Injury (TBI)
Mild Cognitive Impairment (MCI)
Chronic Traumatic Encephalopathy (CTE)
Post-traumatic Stress Disorder (PTSD)
Keywords: Dementia
Traumatic brain injury (TBI)
Mild cognitive impairment (MCI)
Chronic traumatic encephalopathy (CTE)
Remote effects of TBI
Post-traumatic stress disorder (PTSD_
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: University of California, San Francisco
First posted: 2013-07-03
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed description: 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.

Eligibility criteria: 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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Primary outcomes:
measure: Prevalence of dementia or MCI in the two groups (TBI versus no TBI)
timeFrame: Single visit, 4 hours.
Secondary outcomes:
measure: Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI)
timeFrame: Single visit, 4 hours.
Other outcomes:
Locations:
city: Yountville
country: United States
facility: California Veterans Home-Yountville
state: California
city: Washington
country: United States
facility: Armed Forces Retirement Home
state: District of Columbia
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Ramon Diaz-Arrastia, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Kristine Yaffe, MD
role: PRINCIPAL_INVESTIGATOR
References: