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

Contributions of Mild Traumatic Brain Injury to Neurodegeneration Due to Chronic Traumatic Encephalopathy and Alzheimers Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 90 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, MRI scans, Spinal tap (lumbar puncture)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "During the final study session, the investigators will ask subjects to complete (1) an MRI scan, (2) a standard blood draw procedure, and (3) a lumbar puncture procedure."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether Veterans with mild brain injuries are at risk for dementia, which affects memory and thinking. Researchers will study memory, brain waves, brain scans, and proteins linked to brain injury and dementia. The study includes people with brain injuries, people with mild thinking problems, and people with normal thinking skills.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have normal color vision and eyesight of 20/30 or better.
  • Pass the TOMM test, which checks effort during memory testing.
  • Be able to make decisions about joining the study.
  • Be able to safely have a spinal tap, which takes fluid from the lower back. Blood clotting tests and platelet counts must meet study limits.
  • For the mild brain injury group: have a doctor's diagnosis of at least one mild brain injury, with no moderate or severe brain injury.
  • For the moderate brain injury group: have a doctor's diagnosis of at least one moderate brain injury.
  • For the mild thinking problems group: have a specialist's diagnosis, no past brain injury, and thinking test problems that do not limit daily activities or meet the criteria for dementia.
  • For the healthy group: have no past brain injury and score within the study's normal range on thinking tests. Participants will be matched to the mild brain injury group by age, education, and sex.

Who can't join

  • English is not your main language, or you cannot understand and decide about joining the study.
  • Have had a brain injury within the past year. People in the groups without brain injury cannot have any past brain injury.
  • Have thoughts of harming yourself or others that need treatment.
  • Have clinically significant schizophrenia or bipolar disorder.
  • Have active alcohol or drug abuse.
  • Have another significant brain or nerve disease not listed as allowed in the study.
  • Cannot safely have an MRI scan because of implants, metal fragments, clips used to treat a bulging blood vessel, a pacemaker, or pregnancy.
  • Cannot safely have a spinal tap or blood draw. Reasons include blood thinners, aspirin, Plavix, unsafe blood test results, a mass seen on MRI, or an infection near the lower spine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 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

Study sites (1)

MA