Long-term Clinical Correlates of Traumatic Brain Injury

NCT01132898 | Terminated

• 2 other identifiers: 10011810-CC-0118
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, researchers are interested in developing more standardized criteria for diagnosing and classifying different types of traumatic brain injury. By identifying imaging and other indicators immediately after the injury and during the initial treatment phrase, researchers hope to better understand the nature and effects of acute traumatic brain injury. Objectives: \- To study the natural history of traumatic brain injury by examining the changes in brain scans, blood samples, and brain function over 5 years after injury. Eligibility: \- Individuals 18 years of age and older who have had a traumatic brain injury within the past 1 year. Design:

• This study will include about eight visits to the NIH Clinical Center over 5 years. Participants will have four visits in the first year, and one visit each year for the following 4 years. Each visit will take between 1 and 4 days, and participants will be in the outpatient clinic for about 8 hours each day of the visit.
• At each study visit, participants will have some or all of the following tests:
• Medical history and physical examination
• Blood and urine tests
• Questionnaires and assessments of thinking and memory, which may be spoken aloud, written down, or entered into a computer
• Imaging scans, such as magnetic resonance imaging (MRI) or positron emission tomography/computed tomography (PET/CT).
• This study does not provide treatment and does not replace any current therapies. However, participants who are eligible for other National Institutes of Health studies may be referred to these studies by researchers.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Biomarkers; Functional Level; DTI; Neuropsychological Assessment; Natural History

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be to observe changes in the TBI Common Data Elements over time.

  See NINDS Common Data Elements for TBI

  30, 90, 180 days post injury, then annually out to 5 years.

Secondary Outcomes (1)

• Changes in other clinical phenotyping measures over time

  30, 90, 180 days post injury, then annually out to 5 years.

Study Arms (6)

cross-sectional TBI

Participants with a mild, moderate, or severe Traumatic Brain Injury enrolled within 5 years from injury. Seen at only one visit.

HV

Healthy Volunteer with no history of TBI

Prospective TBI

Participants with a mild, moderate, or severe Traumatic Brain Injury enrolled within 1 year from injury.

Remote Select Exposure Samples

Participants who are unable to travel to the NIH Clinical Center to participate can remote consent, answer questionnaires remotely, and have biospecimens sent to our lab for analysis.

Select Exposure Group

US government associated personnel experiencing TBI-like symptoms arising after possible exposure to a non-natural energy source

Select Exposure Matched Unaffected

a longitudinal control group comprised of unaffected volunteers matched to the Select Exposure group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three hundred adult subjects with a clinical diagnosis of non-penetration TBI will be enrolled. One hundred healthy volunteers without a history of TBI will be recruited to compare outcomes to TBI participants. A select exposure group of up to 115 US government associated personnel experiencing TBI-like symptoms arising after possible exposure to a non-natural energy source will be studied. An age and sex matched cohort of non TBI healthy volunteers will be recruited for comparison (n=115). One hundred participants who are unable to travel to the NIH Clinical Center to participate but would like to participate in the study can answer questionnaires remotely, and have biospecimens sent to our lab for analysis.

You may qualify if:

• Diagnosis of non-penetrating mild, moderate, or severe TBI
• Injury occurred less than one year before enrollment
• Age 18 years of age and older
• Able to provide informed consent or with a legally-authorized representative able to provide consent
• Diagnosis of non-penetrating mild, moderate, or severe TBI
• Injury occurred less than five years before enrollment
• Age 18 years of age and older
• Able to provide informed consent or with a legally-authorized representative able to provide consent
• Age 18 and older
• Able to provide written informed consent
• Able to lie flat for up to 2 hours
• Good general medical and psychological health based on History and Physical (H\&P)
• Referral from US State Department, Department of Health and Human Services or other governmental entity based on their assessment of symptomatology and potential exposure (may include, for example, abnormal auditory sensations and subsequent oculomotor, vestibular, and cognitive symptoms)
• Age 18 years of age and older
• Able to provide informed consent or with a legally-authorized representative able to provide consent

You may not qualify if:

• Subjects are not eligible for participation in the prospective cohort if any of the following conditions exist:
• Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a patient s body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the patient s eyes).
• Multiple trauma or accidents in the past with non-certainty that metal objects are still present in the body
• Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
• Pregnant women.
• Women who are breast-feeding may enroll in the study, but will not receive PET-MRI.
• Inability to read or speak enough English to complete the clinical phenotyping testing.
• Medical or Psychological instability such that the subject could not reasonably be expected to fulfill the study requirements.
• Penetrating head injury.
• Subjects are not eligible for participation in the cross-sectional sub-study if any of the following conditions exist:
• Contraindication to MRI scanning including certain metal implants or devices such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitroglycerine) that cannot be removed for the study, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal imbedded in a patient s body (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near the patient s eyes).
• Multiple trauma or accidents in the past with non-certainty that metal objects are still present in the body
• Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
• Pregnant women.
• Inability to read or speak enough English to complete the clinical phenotyping testing.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator
• United States Department of Defense: collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Leighton Chan, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: March 31, 2011
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)