Head InjuryNCT00754169
Warfighter Head Injury Study
An observational study of Head Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine the long-term outcome of brain injuries, the effects of treatment on outcome and the effects of brain injury on people s behavior and abilities. Men and women between 18 and 75 years of age who served in combat in the Iraq war may be eligible for this study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Head Injury
- How many people
- 314 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2008to 9 Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both sexes will be included, however we expect the cohort to be overwhelmingly (>90%) male,
- Age range18-75;
- At least 6 months post-head injury; or
- Those patients who have previously participated in the VHIS.
- Control subjects will be healthy IA warfighter volunteers who are matched to head-injured IA warfighters for time in service, combat exposure, age, gender and preinjury ASVAB scores. All IA warfighter control participants must provide copies of their ASVAB induction testing scores, if applicable; or
- Individuals who have had different blast exposures (e.g., explosives expert) but no documentation of brain injury; or
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- Those warfighter controls who have previously participated in the VHIS.
- Provides care to a Warfighter or,
- Chosen by a control participant as a close companion; and
- Their Warfighter provides informed consent and agrees to participate in the WHIS project.
Who cannot join
- -Any medical condition that, in the judgment of investigators, would make participation detrimental to the patient (e.g.: severe clinical depression, unstable heart disease).
- CONTROLS:
- We will recruit 50 of the VHIS controls, 200 healthy IA warfighter control subjects, with no history of neurologic or serious psychiatric disorder or any other medical condition that would pose a risk from participation (e.g., unstable heart disease) and 120 healthy volunteers with different exposures but no documentation of brain injury. An example of this latter group would include someone who might be employed as a teacher of the proper use of explosive devices (i.e. a trainer from the Bureau of Alcohol, Tobacco and Firearms) and functions well in that position except for an occasional complaint. We will recruit up to a total of 370 normal volunteers.
- We will ask all WHIS controls to travel to the NIH with a companion, some one deemed close to them in terms of relationship (i.e.spouse, child, etc.), to serve as control participants for the caregivers of warfighters. Companions will be asked to complete questionnaires and will execute a separate consent (see Caregiver/Companion Consent Form).
- Neurological or psychiatric conditions as mentioned above;
- History of drug abuse; or
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- Unable to travel independently.
- CAREGIVERS/COMPANIONS:
- We will enroll caregivers and companions (i.e.: family members, domestic partners, etc.) of WHIS Warfighter participants in order to learn more about the potential burden and related issues experienced by this group.
- Inability to provide informed consent; or
- No working knowledge of the English language.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Warfighter Head Injury Study a Comprehensive, Multidisciplinary Research Evaluation
This study will examine the long-term outcome of brain injuries, the effects of treatment on outcome and the effects of brain injury on people s behavior and abilities.
Men and women between 18 and 75 years of age who served in combat in the Iraq war may be eligible for this study. It will compare test results in those who sustained a traumatic penetrating or blast-related brain injury during combat with those who did not.
Read more
Participants undergo the following procedures over a 5-day period of testing that lasts about 6 hours a day:
- Medical history and physical examination.
- Blood test for genetic analysis.
- Electroencephalography (EEG) to measure the electrical activity of the brain.
- MRI or CT scans of the brain to look at the structure and blood flow of the brain.
- Functional near-infrared spectroscopy (fNIRS) to monitor blood flow in the front part of the brain blood by measuring changes in near-infrared light.
- Neuropsychological testing, including questionnaires, pen-and-paper or computerized tests, and performance of simple actions to measure brain function, language, memory and other cognitive abilities..
Read the detailed description
The Warfighter Head Injury Study (WHIS) is a comprehensive, multidisciplinary research study of head-injured warfighters to be conducted at the National Institutes of Health (NIH) in Bethesda, Maryland. The goals of the WHIS include providing clinicians and scientists with new insights into the short term recovery of function following traumatic brain injury (TBI), the role of the prefrontal cortex (PFC) in executive and social functions, and to identify better predictors of short term outcome (including cognitive, neurological, and genetic factors). With the assistance of the Department of Veterans Affairs/Veterans Health Administration (VA/VHA), we propose to contact all Iraqi-Afghan (IA) warfighters with penetrating head injury (PHI), a cohort of blast injured warfighters, and a group of matched (for time in service, combat exposure, age, gender, and preinjury Armed Services Vocational Aptitude Battery [ASVAB] scores) healthy warfighter controls as well as healthy volunteers with different blast exposures (i.e.: explosives experts, artillery operators, etc ) but no documentation of brain injury. We will inquire about their willingness to participate in a comprehensive, multidisciplinary outpatient evaluation conducted at the NIH. In addition to IA warfighters, we also plan to enroll Vietnam warfighters who were included in the W. F. Caveness Vietnam Head Injury Study (VHIS) Registry, in order to conduct detailed comparisons between groups. These cohorts represent a unique opportunity for study; they were healthy and employed before injury, preinjury intelligence testing is available, and the VA/VHA permits long-term follow-up. We have previously investigated Vietnam warfighters with PHI and the published results of those studies have changed the management and evaluation of head-injured warfighters, and contributed to knowledge of brain function and the long-term effects of head injury. Furthermore, based on the knowledge acquired in our previous research with Vietnam warfighters and our current interests in the functions of the human PFC, cognitive neuroplasticity in the young brain, posttraumatic stress disorder (PTSD), posttraumatic epilepsy (PTE), caregiver stress, and genetic-plasticity relationships, we are proposing a series of new cognitive neuroscience experiments and battery of standardized neuropsychological testing to be conducted during the WHIS. In this effort, the experimental testing will be complemented with structural imaging (magnetic resonance imaging [MRI] or computed tomography [CT]), diffusion tensor and perfusion imaging, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and molecular genetics evaluations. This combination of unique patients, cutting edge cognitive neuroscience experiments and state of the art techniques will lead to new scientific knowledge and improved clinical management of warfighters with TBI.
- Conditions
- Head Injury
- Keywords
- Traumatic Brain Injury, Brain Imaging, Brain Plasticity, Neuroplasticity, Neuropsychological Testing, Head Injury, Healthy Volunteer
- Medical subject headings
- Craniocerebral Trauma, Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of focal lesions on neuroplastic changes in cognitive and social functions following combat-related traumatic brain injury
Secondary outcomes (1)
Genetic influence on neuroplastic changes in cognitive and social functions following combat-related traumatic brain injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study start5 Sep 2008
- Study completion9 Jan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- United States Department of Defense, National Institutes of Health Clinical Center (CC), Center for Neuroscience and Regenerative Medicine (CNRM)
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754169
- Sponsor's protocol ID
- 080198
- Other IDs
- 08-N-0198
- Status last verified
- 9 Jan 2013
- First submitted
- 16 Sep 2008
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Abell F, Krams M, Ashburner J, Passingham R, Friston K, Frackowiak R, Happe F, Frith C, Frith U. The neuroanatomy of autism: a voxel-based whole brain analysis of structural scans. Neuroreport. 1999 Jun 3;10(8):1647-51. doi: 10.1097/00001756-199906030-00005.
PubMed 10501551Adolphs R. The neurobiology of social cognition. Curr Opin Neurobiol. 2001 Apr;11(2):231-9. doi: 10.1016/s0959-4388(00)00202-6.
PubMed 11301245Adolphs R. Cognitive neuroscience of human social behaviour. Nat Rev Neurosci. 2003 Mar;4(3):165-78. doi: 10.1038/nrn1056.
PubMed 12612630
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warfighter Head Injury Study a Comprehensive, Multidisciplinary Research Evaluation
- ClinicalTrials.gov ID
- NCT00754169
- Acronym / sponsor ID
- 080198
- Conditions
- Head Injury
- Keywords
- Traumatic Brain Injury, Brain Imaging, Brain Plasticity, Neuroplasticity, Neuropsychological Testing, Head Injury, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 314 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- United States Department of Defense, National Institutes of Health Clinical Center (CC), Center for Neuroscience and Regenerative Medicine (CNRM)
- Study start
- 5 Sep 2008
- Study completion
- 9 Jan 2013
- First posted
- 17 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the long-term outcome of brain injuries, the effects of treatment on outcome and the effects of brain injury on people s behavior and abilities.
Men and women between 18 and 75 years of age who served in combat in the Iraq war may be eligible for this study. It will compare test results in those who sustained a traumatic penetrating or blast-related brain injury during combat with those who did not.
Participants undergo the following procedures over a 5-day period of testing that lasts about 6 hours a day:
- Medical history and physical examination.
- Blood test for genetic analysis.
- Electroencephalography (EEG) to measure the electrical activity of the brain.
- MRI or CT scans of the brain to look at the structure and blood flow of the brain.
- Functional near-infrared spectroscopy (fNIRS) to monitor blood flow in the front part of the brain blood by measuring changes in near-infrared light.
- Neuropsychological testing, including questionnaires, pen-and-paper or computerized tests, and performance of simple actions to measure brain function, language, memory and other cognitive abilities..
Detailed description
The Warfighter Head Injury Study (WHIS) is a comprehensive, multidisciplinary research study of head-injured warfighters to be conducted at the National Institutes of Health (NIH) in Bethesda, Maryland. The goals of the WHIS include providing clinicians and scientists with new insights into the short term recovery of function following traumatic brain injury (TBI), the role of the prefrontal cortex (PFC) in executive and social functions, and to identify better predictors of short term outcome (including cognitive, neurological, and genetic factors). With the assistance of the Department of Veterans Affairs/Veterans Health Administration (VA/VHA), we propose to contact all Iraqi-Afghan (IA) warfighters with penetrating head injury (PHI), a cohort of blast injured warfighters, and a group of matched (for time in service, combat exposure, age, gender, and preinjury Armed Services Vocational Aptitude Battery [ASVAB] scores) healthy warfighter controls as well as healthy volunteers with different blast exposures (i.e.: explosives experts, artillery operators, etc ) but no documentation of brain injury. We will inquire about their willingness to participate in a comprehensive, multidisciplinary outpatient evaluation conducted at the NIH. In addition to IA warfighters, we also plan to enroll Vietnam warfighters who were included in the W. F. Caveness Vietnam Head Injury Study (VHIS) Registry, in order to conduct detailed comparisons between groups. These cohorts represent a unique opportunity for study; they were healthy and employed before injury, preinjury intelligence testing is available, and the VA/VHA permits long-term follow-up. We have previously investigated Vietnam warfighters with PHI and the published results of those studies have changed the management and evaluation of head-injured warfighters, and contributed to knowledge of brain function and the long-term effects of head injury. Furthermore, based on the knowledge acquired in our previous research with Vietnam warfighters and our current interests in the functions of the human PFC, cognitive neuroplasticity in the young brain, posttraumatic stress disorder (PTSD), posttraumatic epilepsy (PTE), caregiver stress, and genetic-plasticity relationships, we are proposing a series of new cognitive neuroscience experiments and battery of standardized neuropsychological testing to be conducted during the WHIS. In this effort, the experimental testing will be complemented with structural imaging (magnetic resonance imaging [MRI] or computed tomography [CT]), diffusion tensor and perfusion imaging, electroencephalogram (EEG), near-infrared spectroscopy (NIRS), and molecular genetics evaluations. This combination of unique patients, cutting edge cognitive neuroscience experiments and state of the art techniques will lead to new scientific knowledge and improved clinical management of warfighters with TBI.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Both sexes will be included, however we expect the cohort to be overwhelmingly (>90%) male,
- Age range18-75;
- At least 6 months post-head injury; or
- Those patients who have previously participated in the VHIS.
- Control subjects will be healthy IA warfighter volunteers who are matched to head-injured IA warfighters for time in service, combat exposure, age, gender and preinjury ASVAB scores. All IA warfighter control participants must provide copies of their ASVAB induction testing scores, if applicable; or
Key exclusion criteria (11 listed)
- -Any medical condition that, in the judgment of investigators, would make participation detrimental to the patient (e.g.: severe clinical depression, unstable heart disease).
- We will recruit 50 of the VHIS controls, 200 healthy IA warfighter control subjects, with no history of neurologic or serious psychiatric disorder or any other medical condition that would pose a risk from participation (e.g., unstable heart disease) and 120 healthy volunteers with different exposures but no documentation of brain injury. An example of this latter group would include someone who might be employed as a teacher of the proper use of explosive devices (i.e. a trainer from the Bureau of Alcohol, Tobacco and Firearms) and functions well in that position except for an occasional complaint. We will recruit up to a total of 370 normal volunteers.
- We will ask all WHIS controls to travel to the NIH with a companion, some one deemed close to them in terms of relationship (i.e.spouse, child, etc.), to serve as control participants for the caregivers of warfighters. Companions will be asked to complete questionnaires and will execute a separate consent (see Caregiver/Companion Consent Form).
- Neurological or psychiatric conditions as mentioned above;
- History of drug abuse; or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The effects of focal lesions on neuroplastic changes in cognitive and social functions following combat-related traumatic brain injury
1 secondary outcome
Genetic influence on neuroplastic changes in cognitive and social functions following combat-related traumatic brain injury
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 10501551Abell F, Krams M, Ashburner J, Passingham R, Friston K, Frackowiak R, Happe F, Frith C, Frith U. The neuroanatomy of autism: a voxel-based whole brain analysis of structural scans. Neuroreport. 1999 Jun 3;10(8):1647-51. doi: 10.1097/00001756-199906030-00005.
- Background: PubMed 11301245Adolphs R. The neurobiology of social cognition. Curr Opin Neurobiol. 2001 Apr;11(2):231-9. doi: 10.1016/s0959-4388(00)00202-6.
- Background: PubMed 12612630Adolphs R. Cognitive neuroscience of human social behaviour. Nat Rev Neurosci. 2003 Mar;4(3):165-78. doi: 10.1038/nrn1056.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects of focal lesions on neuroplastic changes in cognitive and social functions following combat-related traumatic brain injury. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754169, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.