Translocator Protein and Inflammation After Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
Suburban Hospital
United States Uniformed Health Service@@@Bethesda
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT01547780
First received: March 6, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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

Condition Intervention Phase
Traumatic Brain Injury
Healthy
Radiation: PET
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET Imaging of Translocator Protein in Subjects With Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Binding of [(11)C]PBR28.

Secondary Outcome Measures:
  • Neurocognitive assessment scores and clinical evaluations

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: PET
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  • 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.
  • 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 neuological 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547780

Contacts
Contact: Holly Giesen (301) 435-8982 giesenh@imail.nih.gov
Contact: Masahiro Fujita, M.D. (301) 451-8898 fujitam@intra.nimh.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Suburban Hospital
United States Uniformed Health Service@@@Bethesda
Investigators
Principal Investigator: Masahiro Fujita, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT01547780     History of Changes
Other Study ID Numbers: 120063, 12-M-0063
Study First Received: March 6, 2012
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
MRI
Positron Emission Tomograhy (PET)
Inflammation
Microglial Activation
Traumatic Brain Injury
TBI

Additional relevant MeSH terms:
Inflammation
Brain Injuries
Wounds and Injuries
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014