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

Withdrawn

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

• Registration Number: NCT01891383
• Lead Sponsor: Uniformed Services University of the Health Sciences

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.

Study Timeline

• Study First Submitted: 2013-06-25
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-03
• Primary Completion: 2016-06
• Study Completion: 2016-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-16
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of dementia or MCI in the two groups (TBI versus no TBI)	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

Name	Time	Method
Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI)	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.

Trial Locations

Locations (2)

California Veterans Home-Yountville; 🇺🇸 Yountville, California, United States

Armed Forces Retirement Home; 🇺🇸 Washington, District of Columbia, United States