| Eligibility |
- INCLUSION CRITERIA:
Subjects eligible for participation in the TBI prospective cohort must meet the following
inclusion criteria:
- 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
Subjects eligible for participation in the cross-sectional sub-study must meet the
following inclusion criteria:
- 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
Subjects eligible for participation in the healthy volunteer control group must meet the
following inclusion criteria:
- 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)
Subjects eligible for participation in the Select Exposure prospective cohort must meet the
following inclusion criteria:
- 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
Subjects eligible for participation in the Select Exposure Matched Unaffected volunteer
control group must meet the following inclusion criteria:
- Age 18 and older
- Able to provide written informed consent
- Good general medical and psychological health based on History and Physical (H&P)
Subjects eligible for participation in the Remote Select Exposure Samples cohort must meet
the following inclusion criteria:
- 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 (telephone or electronic signature)
EXCLUSION CRITERIA:
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.
- 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 to participate in the Select Exposure cohort if any of the
following conditions exist:
- Pregnant women, may enroll in the study, but will not receive an MRI.
- Women who are breast-feeding may enroll in the study, but will not receive contrast
MRI (gadolinium).
- 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 (such schizophrenia, uncontrolled
hypertension, serious heart, lung, or kidney disease, or other condiditon that would
make participation unsafe)
Subjects are not eligible for participation in the healthy volunteer control group 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).
- Pregnant women
- Inability to read or speak enough English to complete the clinical phenotyping
testing.
- History of a head injury, regardless of cause:.(Causes including: vehicle/bicycle
accidents, falls, sports injuries, firearm injuries, blast injuries, violent shaking,
etc)
- Weight more than 250 lbs.
- Height greater than 6 4
- Any current or prior alcohol or substance abuse.
Heavy alcohol use: The Substance Abuse and Mental Health Services Administration (SAMHSA)
defines heavy alcohol use as binge drinking on 5 or more days in the past month. SAMHSA
defines binge drinking as 5 or more alcoholic drinks for males or 4 or more alcoholic
drinks for females on the same occasion (i.e., at the same time or within a couple of hours
of each other) on at least 1 day in the past month.
Subjects are not eligible for participation in the Select Exposure Matched Unaffected
volunteer group if any of the following conditions exist:
- Pregnant women, may enroll into the study but will not receive an MRI
- Inability to read or speak enough English to complete the clinical phenotyping
testing.
- Any current or prior heavy alcohol or substance use.
- Have a medical or psychological condition, such schizophrenia, uncontrolled
hypertension, serious heart, lung, or kidney disease, or other condition that would
make it difficult for to do the study tests, might make participation unsafe, or would
interfere with the study result
Subjects are not eligible for participation in the Remote Select Exposure Samples group if
any of the following conditions exist:
- Have a blood disorder (such as anemia, bleeding disorders such as hemophilia, blood
clots, and blood cancers such as leukemia, lymphoma, and myeloma) which would make
participation in a blood draw dangerous, or would interfere with the study results
- Have a medical or psychological condition, such schizophrenia, uncontrolled
hypertension serious heart, lung, or kidney disease, or other condition that would
make it difficult to complete the study tests, might make participation unsafe, or
would interfere with the study result
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