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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 90
Healthy Volunteers: t
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⁃ 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

Locations
United States
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
RECRUITING
Boston
Contact Information
Primary
Kristina Morreale, BA
Kristina.Morreale@va.gov
(857) 364-2139
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 800
Treatments
Younger mild Traumatic Brain Injury
mTBI subjects aged 30-59 yo will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). mTBI subjects must pass effort measures on the Test of Memory Malingering (TOMM) and have intact color vision and visual acuity of 20/30 or better in order to be included in the study.
Older mild Traumatic Brain Injury
mTBI subjects aged 60- 90 yo will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). mTBI subjects must pass effort measures on the TOMM and have intact color vision and visual acuity of 20/30 or better in order to be included in the study.
moderate Traumatic Brain Injury
TBI control subjects, age-, education- and sex-matched with mTBI subjects (aged 30-90) will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes (loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, or altered mental status greater than 24 hours). Moderate TBI subjects must pass effort measures on the TOMM and have intact color vision and visual acuity of 20/30 or better in order to be included in the study.
Mild Cognitive Impairment (MCI)
MCI control subjects, age-, education- and sex-matched with older mTBI subjects (aged 60-90) will be recruited if they 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). MCI subjects will be matched for their Montreal Cognitive Assessment (MoCA) score with older mTBI subjects. Of note, subjects with MCI may or may not meet diagnostic criteria for MCI due to AD. The intent of this control group is to recruit a broad range of MCI subjects without TBI as controls for subjects with cognitive impairment who have a history of mTBI.
Younger Healthy Controls
Cognitively normal control subjects, age-, education- and sex-matched with younger mTBI subjects, but lacking and mTBI history. All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled.
Older Healthy Controls
Cognitively normal control subjects, age-, education- and sex-matched with older mTBI subjects, but lacking and mTBI history. All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled.
Authors
Katherin Turk
Sponsors
Leads: VA Office of Research and Development
Collaborators: VA Boston Healthcare System

This content was sourced from clinicaltrials.gov