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

NCT01891383 | Withdrawn

• 2 other identifiers: ERMS# 12lO9006NEU-92-1855
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

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_

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI)

  Single visit, 4 hours.

Study Arms (2)

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).

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• University of California, San Francisco: collaborator

Study Sites (2)

California Veterans Home-Yountville

Yountville, California, 94599, United States

Location

Armed Forces Retirement Home

Washington D.C., District of Columbia, 20011-8400, United States

Location

MeSH Terms

Conditions

Dementia; Brain Injuries, Traumatic; Cognitive Dysfunction; Chronic Traumatic Encephalopathy; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Brain Injury, Chronic; Neurodegenerative Diseases; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Ramon Diaz-Arrastia, M.D., Ph.D.

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

• Kristine Yaffe, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research, Center for Neuroscience and Regenerative Medicine; Professor of Neurology

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 3, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

US (2)