Long-term Clinical Correlates of Traumatic Brain Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 7 January 2013
• Main ID: NCT01132898
• Date of registration: 27/05/2010
• Primary sponsor: National Institutes of Health Clinical Center (CC)
• Public title: Long-term Clinical Correlates of Traumatic Brain Injury
• Scientific title: Long Term Clinical Correlates of TBI: Imaging, Biomarkers, and Clinical Phenotyping Parameters
• Date of first enrolment: May 2010
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01132898
• Study type: Observational
• Study design: Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)

• Name: Andre J Van Der Merwe

• Name: Leighton Chan, M.D.
• Affiliation: National Institutes of Health Clinical Center (CC)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

Subjects eligible for participation in the 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

Any subject enrolled in Dr. Latour's acute TBI protocol (10-N-N122) meeting
inclusion/exclusion criteria of this protocol

Any subject who initially enrolls in the cross-sectional sub-study, but subsequently
agrees to subsequent evaluations

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

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-CT.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Traumatic Brain Injury

Secondary ID(s)

10-CC-0118

100118

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Center for Neuroscience and Regenerative Medicine (CNRM)

Department of Defense