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Clinical Trials/NCT01891383
NCT01891383
Withdrawn
Not Applicable

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

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Uniformed Services University of the Health Sciences
Locations
2
Primary Endpoint
Prevalence of dementia or MCI in the two groups (TBI versus no TBI)
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
August 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ramon Diaz-Arrastia

Director of Clinical Research, Center for Neuroscience and Regenerative Medicine; Professor of Neurology

Uniformed Services University of the Health Sciences

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI)(Single visit, 4 hours.)

Study Sites (2)

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