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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01891383
• Other study ID #: ERMS# 12lO9006
• Secondary ID: NEU-92-1855
• Status: Withdrawn
• Start date: July 2013
• Est. completion date: August 2016

Study information

• Verified date: January 2019
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Chronic Traumatic Encephalopathy
• Chronic Traumatic Encephalopathy (CTE)
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment (MCI)
• Post-traumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury (TBI)
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Armed Forces Retirement Home	Washington	District of Columbia
United States	California Veterans Home-Yountville	Yountville	California

Sponsors (2)

Lead Sponsor	Collaborator
Uniformed Services University of the Health Sciences	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.