RECRUITING

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

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Conditions

Mild Traumatic Brain InjuryModerate Traumatic Brain InjuryMild Cognitive ImpairmentAlzheimer's DiseaseChronic Traumatic EncephalopathyNeurodegeneration

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-07-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04124029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Intact color vision
  2. * Visual acuity of 20/30 (or better)
  3. * Patients must pass effort measures on the TOMM
  4. * Patients must have intact decision-making capacity
  5. * Patients must have no contraindications to lumbar puncture including:
  6. * Being on a blood thinner
  7. * Aspirin or Plavix
  8. * Have no space occupying lesion on magnetic resonance imaging (MRI)
  9. * An International Normalized Ratio (INR) value \< 1.4 and platelet count \>50,000
  10. * No epidural infection or overlying cellulitis over the lumbar spine
  11. * PTSD will be accounted for as a potential confounder and its presence will be included as a covariate in all analyses
  12. * Subjects will be recruited who have a physician diagnosis of 1 or more mTBI episodes without concomitant moderate or severe TBI diagnosis
  13. * Mild TBI: Loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and/or altered mental status greater than 24 hours
  14. * Subjects will be recruited who have a physician diagnosis of 1 or more moderate TBI episodes
  15. * Moderate TBI: loss of consciousness greater than 30 minutes, posttraumatic amnesia greater than 24 hours, and altered mental status greater than 24 hours
  16. * 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
  17. * 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
  18. * Subjects with MCI may or may not meet diagnostic criteria for MCI due to AD
  19. * MCI subjects will be matched for their MoCA score with older TBI subjects
  20. * Cognitively normal control subjects, age-, education- and sex-matched with mild TBI subjects, but lacking and TBI history
  21. * All subjects must be within 1 standard deviation of normal on all neuropsychologic testing in order to be enrolled
  1. * If the primary language is not English
  2. * Are unable to understand the informed consent process
  3. * Have a clinically significant problem with any of the following conditions:
  4. * A history of TBI within 1 year of study
  5. * Suicidal or homicidal ideation requiring intervention
  6. * Schizophrenia
  7. * Bipolar disorder
  8. * Active alcohol or drug abuse
  9. * Clinically significant neurological disease other than those stated in the inclusion criteria
  10. * Impaired decision-making ability
  11. * Patients will be excluded if there are contraindications to MRI including:
  12. * Implants
  13. * Shrapnel
  14. * Aneurysm clips
  15. * Pacemaker
  16. * Pregnancy
  17. * Non-TBI subjects must not have had an TBI
  18. * No contraindication to lumbar puncture or blood draw including:
  19. * Being on a blood thinner
  20. * Aspirin or Plavix
  21. * No space occupying lesion on MRI that makes lumbar puncture contraindicated

Contacts and Locations

Study Contact

Kristina Morreale, BA
CONTACT
(857) 364-2139
Kristina.Morreale@va.gov

Principal Investigator

Katherine Turk, MD
PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Locations (Sites)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Katherine Turk, MD, PRINCIPAL_INVESTIGATOR, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-07-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Mild Traumatic Brain Injury
  • Moderate Traumatic Brain Injury
  • Alzheimer's Disease
  • Chronic Traumatic Encephalopathy
  • Neurodegeneration

Additional Relevant MeSH Terms

  • Mild Traumatic Brain Injury
  • Moderate Traumatic Brain Injury
  • Mild Cognitive Impairment