RECRUITING

Cognitive and Vascular Functioning Following TBI

Conditions

Traumatic Brain Injury Cognitive Decline Vascular Dementia Blood Biomarkers Cerebrovascular Reactivity Military

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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 observational study will examine the association of chronic traumatic cerebrovascular injury and cardiovascular risk factors with TBI-related cognitive impairment and vascular dementia. Cerebrovascular, inflammatory, and neurodegenerative blood biomarkers as well as clinical and neuroimaging data

Official Title

Cognitive and Vascular Functioning Following TBI

Quick Facts

Study Start:2023-11-27

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06034509

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:18 Years to 74 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Active duty uniformed SM or Veteran who is currently eligible for treatment at WRNMMC (i.e., Defense Enrollment Eligibility Reporting System (DEERS)-eligible). 2. Ability to read, write, and speak English. 3. Ability to provide informed consent. 4. NICoE Intensive Outpatient Program (IOP) or NatHx Study comprehensive evaluation ≥3 years prior to current evaluation with valid neuropsychological test results. 5. Consent to allow access to prior research data collected through the NICoE TBI Neuroimaging Core Project or NatHx Study and consent to allow access to at least 1 prior blood specimen previously collected through these studies or the DoD Serum Biorepository. 1. History of at least one mild, moderate, severe, or penetrating TBI \> 3 years prior to enrollment. TBI will be diagnosed if any one of the following criteria immediately after the injury is met and attributed to the brain injury, rather than environmental/psychological/other injury factors (DoD-VA criteria246): 1. Loss of consciousness (LOC) or post-traumatic amnesia (PTA) 2. Alteration of consciousness (AOC) 3. Evidence of neurologic dysfunction 4. TBI-related abnormality on structural neuroimaging (either CT or MRI). Additional Healthy Control Criteria 1. History of military deployment. 2. Low history of blast exposure (i.e., \<10 blasts) Additional Blast Control Criteria 1. History of significant blast exposure (i.e., exposure to ≥ 10 blasts)	1. Disabling neurologic or psychological disorders such as autism, cerebral palsy, developmental disorder, stroke, brain tumor, multiple sclerosis, meningitis, encephalitis, brain abscess, vascular malformation, pre-injury epilepsy, schizophrenia, bipolar disorder, personality disorder 2. Diabetes mellitus requiring drug treatment 3. Hypertension requiring more than 1 antihypertensive drug to control BP 4. History of myocardial infarction or other systemic vasculopathies 5. Dementia diagnosis at initial NICoE/NatHx Study assessment

Inclusion Criteria

Exclusion Criteria

1. Active duty uniformed SM or Veteran who is currently eligible for treatment at WRNMMC (i.e., Defense Enrollment Eligibility Reporting System (DEERS)-eligible).
2. Ability to read, write, and speak English.
3. Ability to provide informed consent.
4. NICoE Intensive Outpatient Program (IOP) or NatHx Study comprehensive evaluation ≥3 years prior to current evaluation with valid neuropsychological test results.
5. Consent to allow access to prior research data collected through the NICoE TBI Neuroimaging Core Project or NatHx Study and consent to allow access to at least 1 prior blood specimen previously collected through these studies or the DoD Serum Biorepository.
1. History of at least one mild, moderate, severe, or penetrating TBI \> 3 years prior to enrollment. TBI will be diagnosed if any one of the following criteria immediately after the injury is met and attributed to the brain injury, rather than environmental/psychological/other injury factors (DoD-VA criteria246):
1. Loss of consciousness (LOC) or post-traumatic amnesia (PTA)
2. Alteration of consciousness (AOC)
3. Evidence of neurologic dysfunction
4. TBI-related abnormality on structural neuroimaging (either CT or MRI). Additional Healthy Control Criteria
1. History of military deployment.
2. Low history of blast exposure (i.e., \<10 blasts) Additional Blast Control Criteria
1. History of significant blast exposure (i.e., exposure to ≥ 10 blasts)

1. Disabling neurologic or psychological disorders such as autism, cerebral palsy, developmental disorder, stroke, brain tumor, multiple sclerosis, meningitis, encephalitis, brain abscess, vascular malformation, pre-injury epilepsy, schizophrenia, bipolar disorder, personality disorder
2. Diabetes mellitus requiring drug treatment
3. Hypertension requiring more than 1 antihypertensive drug to control BP
4. History of myocardial infarction or other systemic vasculopathies
5. Dementia diagnosis at initial NICoE/NatHx Study assessment

Contacts and Locations

Study Contact

Sara M Lippa, PhD

CONTACT

301-319-3671

sara.m.lippa.civ@health.mil

Megan E Glazer, M.S.

CONTACT

301-295-5208

megan.e.glazer.ctr@health.mil

Principal Investigator

Sara M Lippa, PhD

PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Study Locations (Sites)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889

United States

Collaborators and Investigators

Sponsor: Walter Reed National Military Medical Center

Sara M Lippa, PhD, PRINCIPAL_INVESTIGATOR, Walter Reed National Military Medical Center

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 Date2023-11-27

Study Completion Date2027-05

Study Record Updates

Study Start Date2023-11-27

Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

Traumatic Brain Injury
Cognitive Decline
Vascular Dementia
Blood Biomarkers
Cerebrovascular Reactivity
Military

Additional Relevant MeSH Terms

Traumatic Brain Injury
Cognitive Decline
Vascular Dementia