Translocator Protein and Inflammation After Traumatic Brain Injury

• Status: Completed
• Trial end date: 2017-09-28
• Target enrollment: 0
• Participant gender: All

Summary

Background:

• People with traumatic brain injury (TBI) often have inflammation in the brain. A protein called the translocator protein (TSPO) is often present with inflammation. Researchers want to see if a radioactive chemical known as [11C]PBR28 can be used to study TSPO and inflammation in the brain of people with TBI.

Objectives:

• To test whether [11C]PBR28 can be used to study changes in the brain after a traumatic brain injury.

Eligibility:

• Individuals at least 18 years of age who have had TBI and have had a brain scan that shows signs of inflammation.

• Healthy volunteers at least 18 years of age.

Design:

• Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.

• All participants will have two brain scans during an outpatient visit. A magnetic resonance imaging scan will study brain activity. A positron emission tomography (PET) scan will use [11C]PBR28 to look for signs of TSPO and brain inflammation.

• Participants with TBI will have two PET scans within 10 days of the head injury, and a PET scan around 90 days after the injury. They may also have MRI scans under this or another study. Tests of thinking, memory, and concentration will be used to study the effects of the injury and inflammation

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Mental Health (NIMH)
• Collaborators: Suburban Hospital; Uniformed Services University of the Health Sciences

Criteria

-INCLUSION CRITERIA:

Subjects with TBI:

Subjects with TBI eligible for participation in this research study must meet the following inclusion criteria. Depending on the timing of the availability of the subjects the following two groups will be studied. No subject will be enrolled in both group 1 and 2.

Group 1 Acute/subacute phase (n = 20)

• Diagnosis of non-penetrating TBI caused by a head injury within approximately 5 months.

• Ambulatory.

• Able to provide self consent without a legally-authorized representative based on the assessment of the Decision-Making Capacity (DMC) by the Human Subjects Protection Unit (HSPU).

• Show abnormal MRI findings consistent with TBI in protocol 10-N-N122 or in the image database of the CNRM Image Processing Core if the subject is recruited from CNRM Recruitment Core protocol 11-N-0084 or another CNRM protocol that allows referrals to other studies.

• Age 18 or older.

Group 2 Chronic phase (n = 20)

• A head injury approximately 5 months 5 years ago.

• Enrolled in CNRM Recruitment Core protocol 11-N-0084 or another CNRM protocol that allows referral to other studies.

• Meet at least one of the criteria of Probable or Definite TBI established by CNRM.

• Ambulatory.

• Able to provide self consent without a legally-authorized representative based on the assessment of the Decision-Making Capacity (DMC) by the Human Subjects Protection Unit (HSPU).

• Age 18 or older.

Group 3 Healthy subjects.

• Healthy without past or present history of brain disease.

• Age 18 or older.

EXCLUSION CRITERIA:

Subjects with TBI for both groups 1 and 2 are not eligible for participation in this research study if any of the following conditions exist:

1. Present or past history of brain disease other than TBI.

2. Subjects with abnormal MRI findings that suggest a diagnosis other than TBI or a second lesion such as brain tumor in addition to the changes consistent with TBI.

3. Serious medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries. The Medical Advisory Investigator of this protocol will determine whether the subject needs to be excluded.

4. 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 subject'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 subject's eyes).

5. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).

6. In female subjects, pregnancy or breastfeeding.

7. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.

HEALTHY SUBJECTS ARE NOT ELIGIBLE FOR PARTICIPATION IN THIS RESEARCH IF ANY OF THE FOLLOWING CONDITIONS EXIST:

1. Any past or present history of DSM Axis I disorder, with the exception of substance abuse that ended over 6 months prior to enrollment.

2. 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 subject'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 subject's eyes).

3. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).

4. In female subjects, pregnancy or breastfeeding.

5. Clinically significant laboratory abnormalities, as defined as laboratory values that are out of normal range or require clinical workup and/or treatment.

6. Exposure to research related radiation in the past year that, when combined with this study, would place subjects above the allowable limits.

7. Previously determined as a low-affinity binder in another study on TSPO.

8. Positive results of urine drug screen on enrollment.

HIV positive subjects are considered healthy as long as he/she does not show neurological or psychiatric symptoms based on history and physical exams. Results of HIV test in both TBI subjects and healthy controls may help interpretation of the PET results. Statistical analysis: Analysis of date/study outcomes. Results of urine drug screen and history of using drugs of abuse may also help interpretation of the PET results. In addition, inclusion of TBI subjects who show positive for urine drug screen may improve recruitment of TBI subjects.