Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-90
SponsorVA Office of Research and Development

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

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.

    Device

    No 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/Surgery

    No intervention will be used.

Treatment groups

800 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Younger mild Traumatic Brain Injury2 interventions
Group B: Older mild Traumatic Brain Injury2 interventions
Group C: moderate Traumatic Brain Injury2 interventions
Group D: Mild Cognitive Impairment (MCI)2 interventions
Group E: Younger Healthy Controls2 interventions
Group F: Older Healthy Controls2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
5 years

Secondary outcomes

1

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.

Time frame
5 Years
2

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.

Time frame
5 years
3

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.

Time frame
5 years
4

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.

Time frame
5 years

Other outcomes

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