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

Endophenotypes of Dementia Associated With Traumatic Brain Injury in Retired Military Personnel

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.

Study Overview

• Status: Withdrawn
• Conditions: Dementia; Mild Cognitive Impairment (MCI); Traumatic Brain Injury (TBI); Post-traumatic Stress Disorder (PTSD); Chronic Traumatic Encephalopathy (CTE)

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Yountville, California, United States, 94599
      • California Veterans Home-Yountville
  • District of Columbia
    • Washington, District of Columbia, United States, 20011-8400
      • Armed Forces Retirement Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of dementia or MCI in the two groups (TBI versus no TBI)	The primary outcome will be the prevalence of dementia/MCI in the two groups (i.e. those with and without a TBI).	Single visit, 4 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI)	The characterization of the dementia and cognitive impairment within the two groups based on the neuropsychological testing will be secondary outcomes of the study.	Single visit, 4 hours.

Collaborators and Investigators

• Sponsor: Uniformed Services University of the Health Sciences
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Kristine Yaffe, MD, University of California, San Francisco; Principal Investigator: Ramon Diaz-Arrastia, M.D., Ph.D., Uniformed Services University of the Health Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 3, 2013

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: January 16, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Dementia; Traumatic brain injury (TBI); Chronic traumatic encephalopathy (CTE); Mild cognitive impairment (MCI); Remote effects of TBI; Post-traumatic stress disorder (PTSD_
• Additional Relevant MeSH Terms: Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Cognition Disorders; Brain Injury, Chronic; Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries; Dementia; Brain Injuries, Traumatic; Cognitive Dysfunction; Brain Diseases; Chronic Traumatic Encephalopathy
• Other Study ID Numbers: ERMS# 12lO9006; NEU-92-1855 (Other Identifier: USUHS)