Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzh… (NCT04124029) | Clinical Trial Compass
RecruitingNot Applicable
Contributions of mTBI to Neurodegeneration Due to Chronic Traumatic Encephalopathy (CTE) and Alzheimer's Disease (AD)
United States800 participantsStarted 2021-07-01
Plain-language 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.
Who can participate
Age range30 Years – 90 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
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