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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Uniformed Services University of the Health Sciences
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT01891383
First received: June 25, 2013
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Endophenotypes of Dementia Associated With Traumatic Brain Injury in Retired Military Personnel

Resource links provided by NLM:


Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • Prevalence of dementia or MCI in the two groups (TBI versus no TBI) [ Time Frame: Single visit, 4 hours. ] [ Designated as safety issue: No ]
    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:
  • Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI) [ Time Frame: Single visit, 4 hours. ] [ Designated as safety issue: No ]
    The characterization of the dementia and cognitive impairment within the two groups based on the neuropsychological testing will be secondary outcomes of the study.


Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

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

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891383

Contacts
Contact: Kimbra Kenney, M.D. 301 295 6420 kimbra.kenney@usuhs.edu

Locations
United States, California
California Veterans Home-Yountville Recruiting
Yountville, California, United States, 94599
Contact: Carrie Peltz, Ph.D.    415-221-4810 ext 3286    Carrie.Peltz2@va.gov   
Principal Investigator: Kristine Yaffe, MD         
United States, District of Columbia
Armed Forces Retirement Home Active, not recruiting
Washington D.C., District of Columbia, United States, 20011-8400
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
University of California, San Francisco
Investigators
Principal Investigator: Ramon Diaz-Arrastia, M.D., Ph.D. Uniformed Services University of the Health Sciences
Principal Investigator: Kristine Yaffe, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Ramon Diaz-Arrastia, Director of Clinical Research, Center for Neuroscience and Regenerative Medicine; Professor of Neurology, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT01891383     History of Changes
Other Study ID Numbers: ERMS# 12lO9006, NEU-92-1855
Study First Received: June 25, 2013
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Uniformed Services University of the Health Sciences:
Dementia
Traumatic brain injury (TBI)
Mild cognitive impairment (MCI)
Chronic traumatic encephalopathy (CTE)
Remote effects of TBI
Post-traumatic stress disorder (PTSD_

Additional relevant MeSH terms:
Brain Injury, Chronic
Dementia
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Brain Injuries
Cognition Disorders
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Anxiety Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on July 24, 2014