NCT04124029 Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)
| NCT ID | NCT04124029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Mild Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2021-07-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Katherine Turk, MD
PRINCIPAL INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Frequently Asked Questions
Who can join the NCT04124029 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 90 Years, studying Mild Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04124029 currently recruiting?
Yes, NCT04124029 is actively recruiting participants. Contact the research team at Kristina.Morreale@va.gov for enrollment information.
Where is the NCT04124029 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04124029 clinical trial?
NCT04124029 is sponsored by VA Office of Research and Development. The principal investigator is Katherine Turk, MD at VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA. The trial plans to enroll 800 participants.