Examining the link between mild traumatic brain injuries and dementia in veterans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the risk of dementia in veterans who have experienced mild traumatic brain injuries (mTBI). It will assess participants' memory, brain wave activity, brain structure, and levels of specific proteins associated with brain injury and dementia. The study will involve three sessions, including neuropsychological assessments, EEG testing, MRI scans, blood draws, and lumbar punctures to gather comprehensive data on the effects of mTBI. By comparing veterans with mTBI to healthy controls, the research seeks to clarify the relationship between brain injuries and the development of dementia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

All Subjects:

* 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
* Patients must have no contraindications to lumbar puncture including:
* Being on a blood thinner
* Aspirin or Plavix
* Have no space occupying lesion on magnetic resonance imaging (MRI)
* An International Normalized Ratio (INR) value \< 1.4 and platelet count \>50,000
* No epidural infection or overlying cellulitis over the lumbar spine
* PTSD will be accounted for as a potential confounder and its presence will be included as a covariate in all analyses

Mild traumatic brain injury (TBI) Subjects:

* Subjects will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis
* Mild TBI: Loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and/or altered mental status greater than 24 hours

Moderate TBI Subjects:

* Subjects will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes
* Moderate TBI: loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and altered mental status greater than 24 hours

Mild Cognitive Impairment (MCI) Subjects:

* Subjects will be recruited that meet diagnostic criteria for MCI (without a history of TBI) based on the judgement of a behavioral neurologist following the 2011 MCI criteria
* Specifically, subjects will test in the impaired range on one or more cognitive domains on neuropsychological testing and will not have impairments in function, i.e. will not meet diagnostic criteria for dementia
* Subjects with MCI may or may not meet diagnostic criteria for MCI due to AD
* MCI subjects will be matched for their MoCA score with older TBI subjects

Healthy Controls:

* Cognitively normal control subjects, age-, education- and sex-matched with mild TBI subjects, but lacking and TBI history
* All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled

The investigators will recruit all subjects without regard to gender, race, ethnicity, socioeconomic status, or other factors to allow results of this research to yield the greatest generalizability

Exclusion Criteria:

All Subjects:

* If the primary language is not English
* Are unable to understand the informed consent process
* Have a clinically significant problem with any of the following conditions:
* A history of traumatic brain injury (TBI) within 1 year of study
* Suicidal or homicidal ideation requiring intervention
* Schizophrenia
* Bipolar disorder
* Active alcohol or drug abuse
* Clinically significant neurological disease other than those stated in the inclusion criteria
* Impaired decision-making ability
* Patients will be excluded if there are contraindications to MRI including:
* Implants
* Shrapnel
* Aneurysm clips
* Pacemaker
* Pregnancy
* Non-TBI subjects must not have had an TBI
* No contraindication to lumbar puncture or blood draw including:
* Being on a blood thinner
* Aspirin or Plavix
* No space occupying lesion on MRI that makes lumbar puncture contraindicated

Where it's running

• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Katherine Turk, MD — VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
• Study coordinator: Kristina Morreale, BA
• Email: Kristina.Morreale@va.gov
• Phone: (857) 364-2139

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.