About this trial
This is a research study that aims to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Intact color vision
Visual acuity of 20/30 (or better)
Patients must pass effort measures on the TOMM
Patients must have intact decision-making capacity
Disqualifiers
If the primary language is not English
Are unable to understand the informed consent process
A history of traumatic brain injury (TBI) within 1 year of study
Suicidal or homicidal ideation requiring intervention
Trial population
Patients from the memory disorders clinic will be recruited if they have a (1) history of mild TBI, (2) history of moderate TBI, or (3) mild cognitive impairment. In addition, the investigators will be recruiting healthy controls that meet satisfy the inclusion and exclusion criteria of the study.
Trial design
Case-control
Prospective
Treatments tested in this trial
No Intervention is used for this study but all subjects will be asked to complete electroencephalogram (EEG) testing and an MRI scan.
DeviceNo intervention will be used.
No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.
Procedure/SurgeryNo intervention will be used.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
To better understand the contribution of mild Traumatic Brain Injury (mTBI) to neurodegeneration with the intent of detecting early behavioral, physiologic, anatomic, and protein evidence of neurodegeneration due to AD and CTE
The work proposed will allow exploration of the relationships between behavioral, event-related potential (ERP), MRI, and cerebrospinal fluid (CSF) measures at a variety of points along the disease continuum and will allow for future longitudinal studies in this cohort
Secondary outcomes
Recognition Memory
Recognition memory will be examined using behavioral estimation techniques to see if recognition memory will be worse in patients with an increased number of mild TBI and with increased time since mild TBI.
Electroencephalogram (EEG) peak amplitude and latency
The investigators are trying to see if electrophysiological correlates of recollection will be decreased in patients with a greater number of mTBI episodes and those with increased time since mTBI episodes; and if the electrophysiological correlates of familiarity will be decreased in patients with dementia who have imaging and cerebrospinal fluid (CSF) biomarkers consistent with neurodegeneration.
Cortical, quantitative MRI volume measurements
The investigators are trying to see if global cortical atrophy, hippocampal and extrahippocampal medial temporal lobe (MTL) atrophy will be increased in patients with a greater number of mTBI episodes and those with increased time since mTBI episodes.
CSF Proteinopathy
The investigators are trying to see if a cerebrospinal fluid (CSF) proteinopathy will be present in patients with a greater number of mTBI episodes and those with increased time since mTBI episodes.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
VA Boston Healthcare System
Collaborator