Examining the link between mild traumatic brain injuries and dementia in veterans
Contributions of Mild Traumatic Brain Injury to Neurodegeneration Due to Chronic Traumatic Encephalopathy and Alzheimers Disease
This study is trying to see if veterans who have had mild traumatic brain injuries are more likely to develop dementia compared to those who haven't had such injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 30 Years to 90 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04124029 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include veterans with a history of mild to moderate traumatic brain injuries and those with mild cognitive impairment.
Not a fit: Patients with severe traumatic brain injuries or contraindications to lumbar puncture may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify veterans at risk for dementia, leading to earlier interventions and improved patient outcomes.
How similar studies have performed: Other studies have explored the effects of traumatic brain injuries on cognitive decline, suggesting potential for significant findings in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 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 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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.