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Research

Blood Biomarker Candidate Study of Mild Traumatic Brain Injury

IRB Number: 2015-788
(inactive trial)

Institutional Review Board, Hospital for Special Surgery

October 25, 2016

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Teena Shetty, MD

Co-Investigators

Taylor E. Cogsil
Aashka P. Dalal
Hannah R. Ferderber,
Lauren Langford
Kelianne Cummings

Summary

This is a multicenter center with a total proposed enrollment of 500. The Hospital for Special Surgery site has a proposed enrollment of 100. We have currently enrolled 76 individuals. 58 of these are mTBI patients and 18 are controls. Our enrollment period for mTBI patients began on January 13, 2015 and the enrollment period for controls began on August 24, 2015. The enrollment period will end when the proposed enrollment is reached. Adolescents and adults diagnosed with mTBI due to sports injury, bicycle injury, and other emergency trauma may be enrolled in this study.  Patients that are enrolled in GE Study Number 114-2013-GES-0017 “Advanced MRI Applications for Mild Traumatic Brain Injury” will be asked if they want to enroll in this biomarker study.  Only patients enrolled in the GE study will be eligible to participate in the Blood Biomarker Candidate Study for mTBI. In addition, non-TBI subjects may be enrolled in the GE study as imaging controls.  These subjects will be asked if they will be willing to provide a blood sample for the Abbott study.  Only control subjects enrolled in the GE study will be eligible to participate as controls for the Blood Biomarker Candidate study for mTBI.   This study includes up to four visits for adults. These occur within 72 hours of injury, 5-9 days from injury, 12-16 days from injury, and 83-97 days from injury. If enrolling within 72 hours of injury, four 10mL tubes of blood are drawn two times between 3 and 6 hours apart. At the following encounters, four 10mL tubes of blood will be drawn. Minors will only have two visits. The first will occur when they enroll either within 72 hours or between 5-9 days from injury. The second occurs between 83-97 days from injury. Two 10mL tubes of blood will be drawn twice between 3 and 6 hours apart if enrolling within 72 hours. Two 10mL tubes of blood will be drawn if enrolling at 5-9 days from injury. Two 10mL tubes of blood will be drawn at the last visit 83-97 days after injury.

Inclusion/Exclusion Criteria

These inclusion criteria meet the inclusion criteria in GE Study Number 114-2013-GES-0017 “Advanced MRI Applications for Mild Traumatic Brain Injury”.

  1. Be age ≥15 and ≤50 years old at time of enrollment.
  1. Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment in one of the two intervals of the study, as follows:
    1. Meets criteria for enrollment in Encounter 1 (within 72 hours)
    2. Meets criteria for enrollment in Encounter 2 (within 8±2 days)
  2. Be willing to participate in all study activities and provide written informed consent for participation
  3. Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors.

Exclusion Criteria for mTBI subjects

These exclusion criteria meet the inclusion criteria in GE Study Number 114-2013-GES-0017 “Advanced MRI Applications for Mild Traumatic Brain Injury”.

1. Loss of consciousness (LOC) ≥15 minutes;

2. Posttraumatic amnesia lasting ≥24 hr following a recent TBI event;

3. Diagnosis of moderate to severe TBI or GCS <13;

4. Structural brain injury indicated by previous neuroimaging findings;

5. Previous history of moderate to severe TBI;

6. Any previous history of mild TBI within the past 12 months;

7. Previously diagnosed brain white matter disease;

8. History of seizures within the past 10 years;

9. History of self-reported recreational drug usage in past 10 years;

10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);

11. Current primary Axis I or II psychiatric disorder

12. History of brain mass

13. History of neurosurgery

14. History of stroke

15. History of dementia

16. Known cognitive dysfunction

17. Known structural brain disease or malformation

18. Current anti-psychotic, psychotropic, or antiepileptic medication usage

19. That are unable or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;

20. Contraindications to MRI scanning, including:

a. Current or suspected pregnancy per site clinical practice;

b. Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;

c. Inability to comply with any part of the site’s MR safety policy.

Inclusion Criteria for non-TBI subjects

These inclusion criteria meet the inclusion criteria in GE Study Number 114-2013-GES-0046 “Advanced MRI Applications for Mild Traumatic Brain Injury Study 3”.

All included subjects will:

  1. Aged ≥15 and ≤50 years old at the time of enrollment;
  1. Be well matched to one or more mTBI patients in Segment 1, in the opinion of the Principal Investigator, with regards to:
    1. Age,
    2. Gender,
    3. Sociodemographic characteristics, and
    4. Handedness.
  1. Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors.

Exclusion Criteria for Non-TBI subjects

These exclusion criteria meet the inclusion criteria in GE Study Number 114-2013-GES-0046 “Advanced MRI Applications for Mild Traumatic Brain Injury Study 3”.

Subjects will be excluded that:

  1. Are currently pregnant based on subject self-report of pregnancy status;
  2. Are currently enrolled in another Segment of this study;
  3. Require medical care that would be adversely affected or delayed by participating, in the opinion of a physician investigator;
  4. Prior diagnosis of mild TBI within the past 12 months;
  5. Have structural brain injury indicated by previous neuroimaging findings;
  6. Previous history of moderate to severe TBI within the past 10 years;
  7. Previously diagnosed brain white matter disease;
  8. History of seizures within the past 10 years;
  9. History of illicit drug abuse (except marijuana) within the past 10 years
  10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
  11. Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity
  12. History of brain mass;
  13. History of neurosurgery;
  14. History of stroke;
  15. History of dementia;
  16. Known cognitive dysfunction;
  17. Known structural brain disease or malformation;
  18. Current anti-psychotic or antiepileptic medication usage;
  19. Have contraindications to MRI scanning, including:
    1. Current or suspected pregnancy per site clinical practice;
    2. Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator;
    3. Inability to comply with any part of the site’s MR safety policy.

Contact Information

Taylor Cogsil
cogsilt@hss.edu
646.714.6278